FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC met twice in 2004 and set up temporary working groups to review and update available guidance that was adopted by the Herbal Medicinal Products Working Party (HMPWP) between 1997 and 2004, and to identify the need for additional guidance in the quality, safety and efficacy fields or on organisational matters.
Danish: HMPC havde to møder i 2004 og nedsatte midlertidige arbejdsgrupper til at gennemgå og ajourføre de eksisterende retningslinjer, som var vedtaget af arbejdsgruppen vedrørende plantelægemidler (HMPWP) mellem 1997 og 2004, og afdække behovet for yderligere retningslinjer vedrørende kvalitet, sikkerhed og virkninger samt organisatoriske spørgsmål.
English: • Discussed large number of contributions received from patients and healthcare professionals groups, the pharmaceutical industry, national competent authorities, national health ministries, European institutions and others as part of the Road Map to 2010 consultation process
Danish: • drøftelse af de mange bidrag fra patientorganisationer, faglige organisationer inden for sundhedssektoren, lægemiddelindustrien, nationale sundhedsministerier og andre ansvarlige myndigheder, EU-institutioner og andre interesserede parter som led i høringsprocessen omkring "køreplanen frem til 2010"
English: The EMEA coordinates the verification of compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP), and with certain aspects of the supervision of authorised medicinal products in use in the EU, through inspections requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation.
Danish: EMEA koordinerer kontrollen af overholdelsen af principperne for god fremstillingspraksis (GMP), god klinisk praksis (GCP) og god laboratoriepraksis (GLP) samt visse aspekter af tilsynet med lægemidler, der er godkendt til brug i EU, gennem inspektioner bestilt af CHMP eller CVMP i forbindelse med vurderingen af ansøgninger om markedsføringstilladelse og/eller vurderingen af spørgsmål, der henvises til disse udvalg i medfør af EU-lovgivningen.
English: By providing scientific advice, the Agency helps companies to research and develop new medicines and to further their scientific exploration in areas such as emerging therapies.
Danish: Ved at yde videnskabelig rådgivning hjælper agenturet medicinalvirksomhederne til at forske i og udvikle nye lægemidler og fremmer den videnskabelige udforskning på områder som f.eks. nye behandlingsformer.
English: This project was successfully launched in 2004, providing EMEA users with a directory (ECD) based on LDAP.
Danish: Projektet blev gennemført i 2004 med godt resultat og har givet EMEA-brugere en adresseliste baseret på LDAP.
English: The standard operating procedure (SOP) and web guidance document were revised considerably, taking into account comments received from interested parties.
Danish: Den operationelle standardprocedure og web-vejledningen blev gennemgribende revideret for at tage hensyn til kommentarer fra forskellige relevante parter.
English: After the EU enlargement on 1 May 2004, the CVMP met for the first time with members from the new Member States.
Danish: Efter EU's udvidelse den 1. maj 2004 holdt CVMP sit første møde med deltagelse af medlemmer fra de nye medlemsstater.
English: 4.1 Inspections
Danish: 4.1 Inspektioner
English: 3-tier architecture
Danish: 3-lags arkitektur
English: The Committee, while taking into account the position expressed by the SAG, remains responsible for its final opinion.
Danish: CHMP tager hensyn til den holdning, den pågældende SAG giver udtryk for, men er eneansvarlig for den endelige udtalelse.
English: Working parties
Danish: Arbejdsgrupper
English: 1.4 European medicines network
Danish: 1.4 Det europæiske lægemiddelnetværk
English: Upon request from the EMEA, national competent authorities have nominated more than 100 specialised experts in the areas of pharmacovigilance, pharmacoepidemiology, epidemiology, emerging therapies (such as gene therapy) and risk communication.
Danish: De nationale ansvarlige myndigheder har efter anmodning fra EMEA udpeget over 100 eksperter inden for områderne lægemiddelovervågning, farmakoepidemiologi, nye behandlingsformer (f.eks. genterapi) og risikokommunikation.
English: As in previous years, the scientific support given to the EMEA by the national competent authorities was excellent.
Danish: Ligesom tidligere år fik EMEA glimrende videnskabelig støtte fra de nationale ansvarlige myndigheder.
English: An EMEA PAT team was created in January 2004 to review the implications of PAT with a view to ensuring that the European regulatory framework and the authorities are prepared for and adequately equipped to conduct thorough and effective evaluations of PAT-based submissions.
Danish: I januar 2004 blev der oprettet en PAT-gruppe i EMEA, som skulle gennemgå implikationerne af PAT for at sikre, at EU-lovgivningen og myndighederne er tilstrækkeligt forberedt og rustet til at vurdere PAT-baserede ansøgninger.
English: Hannes Wahlroos (Alternate: Pekka JÄRVINEN)
Danish: Hannes Wahlroos (suppleant: Pekka JÄRVINEN)
English: Two working parties and one ad hoc group assist the Committee:
Danish: Udvalget bistås af to arbejdsgrupper og en ad hoc-gruppe:
English: The Agency also provides secretarial support to the Joint CHMP/CVMP Quality Working Party (QWP) that continued with the development of EU quality guidelines, support to ICH, and cooperation with the European Directorate for the Quality of Medicines (EDQM).
Danish: Agenturet varetager desuden sekretariatsfunktionerne for den fælles CHMP/CVMP-arbejdsgruppe vedrørende kvalitet (QWP), der fortsatte med at udarbejde EU-retningslinjer på kvalitetsområdet, yde støtte til ICH og samarbejde med Det Europæiske Direktorat for Lægemiddelkvalitet (EDQM).
English: An inventory accounting system was implemented and all data, including tangible and intangible assets, were uploaded to the system.
Danish: Der blev indført et nyt opgørelsessystem, og alle data omfattende både materielle og immaterielle aktiver blev indlæst i systemet.
English: 3.4 Availability of medicines for minor use and minor species
Danish: 3.4 Lægemidler til mindre udbredte sygdomme og mindre arter
English: The past year also marked a milestone in the development of the EU pharmaceutical legislation and the enlargement of the EU.
Danish: Det forgangne år markerede samtidig en milepæl i udviklingen af EU's lægemiddellovgivning og var også året for EU's store udvidelse.
English: Pharmacovigilance is a priority area for the Agency and, as a consequence, the EMEA will continue and further strengthen its efforts in order to ensure the safe use of products licensed in accordance with the centralised procedure.
Danish: Lægemiddelovervågning er et prioriteret aktivitetsområde for agenturet, og EMEA vil i konsekvens heraf fortsætte og yderligere forstærke sin indsats for sikker brug af produkter, der er godkendt efter den centraliserede procedure.
English: Whereas 12 type-II variations had been forecast, the EMEA actually received 16, of which 12 concerned pharmaceuticals and 4 concerned vaccines.
Danish: Der var forventet 12 ansøgninger om type II-ændringer, men EMEA modtog 16 sådanne ansøgninger, hvoraf de 12 vedrørte farmaceutiske produkter, og 4 vedrørte vacciner.
English: The CVMP nominated additional members as follows: one expert on quality aspects of biotechnology products; three experts on clinical medicine (one for companion animals, one for large animals and one for intensive production, with a focus on poultry); and one expert on safety and risk assessment.
Danish: CVMP indvalgte således en ekspert i de kvalitetsmæssige aspekter ved bioteknologiske produkter, tre eksperter i klinisk medicin (en for kæledyr, en for større dyr og en for intensiv produktion med fokus på fjerkræ) samt en ekspert i sikkerheds- og risikovurdering.
English: Isabelle MOULON See Annexes 2, 4 and 5 for members of committees, working parties and ad hoc groups.
Danish: Isabelle MOULON Bilag 2, 4 og 5 indeholder en fortegnelse over udvalgsmedlemmer, arbejdsgrupper og ad hoc-grupper.
English: Infrastructure services
Danish: Infrastrukturtjenester
English: The implementation of new Community legislation in October 2003 split type-I variations into typeIA and type-IB variations, and also converted about 25 % of the former quality-related type-I variations into type-II variations.
Danish: I den nye EU-lovgivning fra oktober 2003 blev type I-ændringer opdelt i type IA- og type IBændringer, og ca. 25 % af de tidligere kvalitetsrelaterede type I-ændringer overgik til at blive type IIændringer.
English: Companies submitted 8 new applications for veterinary medicines in 2004, of which 4 were for immunologicals and 4 were for pharmaceuticals, including 1 generic.
Danish: I 2004 indgav virksomheder otte nye ansøgninger for veterinærlægemidler, hvoraf fire vedrørte immunologiske præparater, og fire vedrørte farmaceutiske præparater, herunder et generisk.
English: Agnès SAINT-RAYMOND (from mid-October 2004)
Danish: Agnès SAINT-RAYMOND (fra medio oktober 2004)
English: Annex 7 EMEA budget summaries 2003-2005
Danish: Bilag 7 Sammendrag af EMEA's budgetter 2003-2005
English: Guidance documents focusing on the key steps of the centralised procedure are continuously developed and updated by the EMEA.
Danish: Det skriftlige vejledningsmateriale fokuserer på de vigtigste led i den centraliserede procedure, og EMEA videreudvikler og ajourfører det løbende.
English: Pat O MAHONY (Alternate: Joan GILVARRY)
Danish: Pat O'MAHONY (suppleant: Joan GILVARRY)
English: As part of the confidentiality arrangements with the US FDA, a pilot scheme was launched to give parallel scientific advice.
Danish: Som led i ordningen med US FDA blev der iværksat en pilotplan vedrørende tilbud om parallel videnskabelig rådgivning.
English: The EMEA cooperates closely with other scientific and regulatory institutions and agencies in the public health arena at European Union level.
Danish: EMEA arbejder tæt sammen med andre videnskabelige og regeludstedende institutioner og agenturer på sundhedsområdet i EU.
English: This was to enable a more phased approach and address potential public health concerns.
Danish: Formålet var at skabe forudsætninger for en mere trinvis fremgangsmåde og få afdækket og behandlet eventuelle problemer i relation til folkesundheden.
English: • Patrick SALMON2 (Ireland)
Danish: • Patrick SALMON2 (Irland)
English: GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
Danish: GMP er en del af den kvalitetssikring, der skal give garanti for, at lægemidler altid er fremstillet og kontrolleret i henhold til de kvalitetsstandarder, der er relevante for produkternes tilsigtede anvendelse.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for formulating the Agency's scientific opinions regarding the quality, safety and efficacy of medicinal products for veterinary use and the establishment of maximum residue limits.
Danish: Udvalget for veterinærlægemidler (CVMP) har ansvaret for udarbejdelsen af agenturets videnskabelige udtalelser om veterinærlægemidlers kvalitet, sikkerhed og virkninger og for fastsættelse af maksimale grænseværdier for restkoncentrationer.
English: Annex 8 IT projects and operational activities Annex 9 CHMP opinions in 2004 on medicinal products for human use Annex 10 CVMP opinions in 2004 on medicinal products for veterinary use Annex 11 COMP opinions in 2004 on designation of orphan medicinal products Annex 12 Guidelines and working documents in 2004
Danish: Bilag 8 IT-projekter og operationelle aktiviteter Bilag 9 CHMP-udtalelser i 2004 om humanmedicinske lægemidler Bilag 10 CVMP-udtalelser i 2004 om veterinærlægemidler Bilag 11 COMP-udtalelser i 2004 om udpegelse af lægemidler til sjældne sygdomme Bilag 12 Retningslinjer og arbejdsdokumenter i 2004
English: Important responsibilities of the CVMP include the preparation of regulatory guidelines for the veterinary pharmaceuticals industry as well as the provision of assistance to companies researching and developing new veterinary medicines.
Danish: Blandt CVMP's vigtigste opgaver er at udarbejde forskriftsmæssige retningslinjer for veterinærlægemiddelindustrien og yde bistand til virksomheder, der forsker i og udvikler nye veterinærlægemidler.
English: This reflects the upward trend in the number of applications that has been experienced since the shortfall in 2002, with the highest number of active substances in the past five years.
Danish: Det afspejler den generelt stigende tendens i antallet af ansøgninger siden faldet i 2002, og man nåede op på det højeste antal aktive stoffer inden for de seneste fem år.
English: The MMS includes an Experts database and enables the automation of many administrative documents, such as invitations, participation lists and reimbursement forms, and the setting up of a tracking system for hotel and travel details.
Danish: Systemet omfatter en database over eksperter og gør det muligt at automatisere mange administrative dokumenter som f.eks. invitationer, deltagerlister og godtgørelsesformularer samt etablere et tracking-system for rejse- og hotelinformationer.
English: Members European Parliament
Danish: Medlemmer Europa-Parlamentet
English: In 2004, the regulatory time for proceeding through the centralised procedure remained stable, at an average of 288 days, including 187 days for assessment.
Danish: Den formelle sagsbehandlingstid i forbindelse med den centraliserede procedure var nogenlunde uændret i 2004, dvs. gennemsnitligt 288 dage, heraf 188 dage til vurderingen.
English: Similar rules were adopted by all EU agencies to bring them in line with other EU institutions.
Danish: Alle EUagenturerne har vedtaget tilsvarende regler for at bringe deres praksis på området på linje med de
English: • The CHMP reviewed and gave a positive opinion for the first proteosome inhibitor, which is indicated for the treatment of a form of cancer of the blood
Danish: • CHMP undersøgte og afgav positiv udtalelse om den første proteosom-inhibitor til behandling af en form for cancer i blodet.
English: • Lars GRAMSTAD (Norway)
Danish: • Lars Gramstad (Norge)
English: Based on the findings of the audit, an action plan was developed to implement the opportunities for improvement identified.
Danish: Der blev udarbejdet en handlingsplan på grundlag af konklusionerne af denne revision for at udnytte de påpegede muligheder for forbedringer.
English: Ad hoc Meeting of GCP Inspection Services
Danish: Ad hoc-møde for GCP-inspektionstjenester
English: Work is ongoing with respect to harmonised rapid alert procedures and annual reporting provisions.
Danish: Der arbejdes fortsat på at få indført harmoniserede alarmeringsprocedurer og vedtaget bestemmelser om årlige indberetninger.
English: Following this, a new career structure was implemented, as were changes to grading and allowances etc., which are being applied to existing staff and new recruits.
Danish: Det indebar en ny karrierestruktur og ændringer med hensyn til indplacering, tillæg m.m., som gælder både for det eksisterende personale og for nye ansatte.
English: The EMEA provided full secretariat and administrative support to the group.
Danish: EMEA varetog alle sekretariatsfunktioner og administrative funktioner for gruppen.
English: • The CVMP's preparation for enlargement of the European Union proved more than adequate, with the restructuring of the Committee in accordance with the revised pharmaceutical legislation taking place smoothly and without any difficulty.
Danish: • CVMP's forberedelser til EU's udvidelse lykkedes over al forventning, og omstruktureringen af udvalget i overensstemmelse med den reviderede lægemiddellovgivning forløb gnidningsløst og helt uden problemer.
English: The Committee for Medicinal Products for Human Use (CHMP), the Committee on Orphan Medicinal Products (COMP) and the Committee on Herbal Medicinal Products (HMPC) are responsible for formulating the Agency's opinions on all questions concerning medicinal products for human use.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP), Udvalget for Lægemidler til Sjældne Sygdomme (COMP) og Udvalget for Plantelægemidler (HMPC) er ansvarlige for udarbejdelsen af agenturets udtalelser om alle spørgsmål vedrørende humanmedicinske lægemidler.
English: EMEA contact: Isabelle MOULON
Danish: EMEA-kontakt: Isabelle MOULON
English: Hepatitis B virus surface antigen (rDNA) (S protein) !
Danish: Fendrix Hepatitis B virus surface antigen (rDNA) (S protein) Part A
English: The new Financial Regulation allows the Agency to build up a reserve from positive balance out-turns.
Danish: Den nye finansforordning giver agenturet mulighed for at anvende et eventuelt positivt budgetresultat til at opbygge en reserve.
English: This included class labellings for all antiretroviral medicinal products with regard to liver impairment and immune reactivation syndrome, and a statement on mitochondrial toxicity in children with postnatal or in utero exposure to nucleotide and nucleoside analogues.
Danish: Det omfattede bl.a. "klassemærkninger" af alle antiretrovirale lægemidler i relation til nedsat leverfunktion og immunreaktiveringssyndrom samt oplysning om mitokondrial toksicitet hos børn med postnatal eller in utero eksponering for nukleotide eller nukleoside analogpræparater.
English: The smooth operation of EMEA internal information technology systems is critical to the Agency s ability to perform its tasks.
Danish: EMEA's interne IT-systemer er af afgørende betydning for agenturets mulighed for at varetage sine opgaver.
English: • Major work was undertaken in 2004 in relation to the further development and implementation of the EudraVigilance project.
Danish: • Der blev i 2004 gjort en stor indsats for at få EudraVigilance-projektet udbygget og gennemført.
English: In addition, following the finalisation of the USR, it is common for the company concerned to inform healthcare professionals by means of a Dear Doctor letter in all EU countries where the medicine is marketed.
Danish: Det er desuden normalt, at den pågældende virksomhed informerer fagfolk i sundhedssektoren via et "Dear Doctor Letter" i alle de EU-lande, hvor lægemidlet markedsføres.
English: Referral procedures under Articles 31, 36 and 37 of Directive 2001/83/EC are mainly initiated in cases involving the interests of the Community or concerns relating to the protection of public health.
Danish: Henvisningsprocedurer i henhold til artikel 31, 36 og 37 i direktiv 2001/83/EF benyttes i sager, der berører EU's interesser eller beskyttelsen af folkesundheden.
English: To ensure that the Agency s processing and storage capabilities are aligned to its business workload
Danish: Sikkerhed for, at agenturets databehandlings- og lagerkapacitet er tilstrækkelig i forhold til arbejdsmængden
English: Val DIEZ1 (Alternate: José MARTINEZ OLMOS)
Danish: Val DIEZ1 (suppleant: José MARTINEZ OLMOS)
English: The year s most notable evaluations concerned:
Danish: Årets mest betydningsfulde vurderinger vedrørte følgende:
English: Operational since 29 May 2004
Danish: Operationel siden 29.5.2004
English: Although the implementation rate at the level of Member States and pharmaceutical industry has remained low, the EMEA took several initiatives in 2004 to stimulate electronic reporting of individual case safety reports (ICSRs).
Danish: Selv om det fortsat går langsomt med at få medlemsstaterne og lægemiddelindustrien til at medvirke effektivt, tog EMEA flere initiativer i 2004 for tilskynde til elektronisk fremsendelse af individuelle sikkerhedsindberetninger (ICSR).
English: The business objects reporting tool was also installed so that standard financial reports on asset purchases and depreciation could be produced.
Danish: Der blev ligeledes installeret et såkaldt "business objects reporting tool" til udarbejdelse af standardiserede regnskabsrapporter om køb og afskrivning af aktiver.
English: A major step towards improving the quality of the EU regulatory network as a whole was the agreement between the heads of regulatory agencies to introduce an EU benchmarking system.
Danish: Det var et vigtigt skridt mod en højnelse af kvaliteten af EU's regelværk som helhed, da cheferne for medlemsstaternes lægemiddelstyrelser besluttede at indføre et EU-benchmarkingsystem.
English: In anticipation, some marketing authorisation holders (MAHs) already submitted risk management plans for review by the CHMP during 2004, and several meetings with MAHs for centrally authorised products were held in 2004, mainly to discuss risk management concepts.
Danish: Nogle indehavere af markedsføringstilladelser havde allerede på forhånd forelagt risikostyringsplaner, som CHMP skulle gennemgå i 2004, og der blev i årets løb afholdt flere møder med indehavere af markedsføringstilladelser for centralt godkendte produkter, hvor man primært drøftede risikostyringskoncepter.
English: Seventy-eight GMP inspections were requested in 2004; 40 % of these related to requests for reinspection of sites already inspected two to three years previously.
Danish: Der blev i 2004 anmodet om 79 GMP-inspektioner; heraf vedrørte 40 % fornyet inspektion af anlæg, der var blevet inspiceret to-tre år tidligere.
English: At the beginning of 2004, the EMEA launched an exercise to create a new long-term strategy for the Agency that would contribute to better protection and promotion of public and animal health, improve the regulatory environment for medicinal products, and help to stimulate innovation, research and development in the EU.
Danish: I starten af 2004 påbegyndte EMEA arbejdet med at udvikle en ny langsigtet strategi for agenturet, som skal bidrage til at sikre bedre beskyttelse og fremme af folkesundheden og dyrs sundhed, danne grundlag for en bedre lægemiddellovgivning og stimulere innovation, forskning og udvikling i EU.
English: The EMEA continually supported the Commission and the Member States with the implementation of Directive 2001/20/EC on clinical trials through the activities of the ad hoc meetings of GCP and GMP inspection services, through participation in working groups of the Commission, and through support to the implementation of European databases for clinical trials.
Danish: EMEA bistod løbende Europa-Kommissionen og medlemsstaterne med implementeringen af direktiv 2001/20/EF om kliniske forsøg via drøftelserne på GCP- og GMP-inspektionstjenesternes ad hocmøder, deltagelse i Kommissionens arbejdsgrupper og støtte til arbejdet med etableringen af europæiske databaser om kliniske forsøg.
English: The volume of applications for scientific assessment of medicinal products for human use was substantially higher than in 2003, with 21 more applications for orphan medicine designation, 25 more requests for scientific advice and protocol assistance, 12 more applications for initial marketing evaluation, 8 more opinions on initial marketing evaluation, and 61 more post-authorisation opinions.
Danish: Der indkom væsentligt flere ansøgninger om faglige vurderinger af humanmedicinske lægemidler end i 2003: 21 flere ansøgninger vedrørende lægemidler til sjældne sygdomme, 25 flere anmodninger om videnskabelig rådgivning og protokolbistand, 12 flere ansøgninger om indledende vurdering med henblik på markedsføringstilladelse, og der blev afgivet 8 flere udtalelser om indledende vurderinger med henblik på markedsføringstilladelse og 61 flere udtalelser efter godkendelse.
English: One GLP inspection was requested in 2004.
Danish: Der blev i 2004 anmodet om en GLP-inspektion.
English: The objectives of the sampling and testing programme, derived from the legal requirements, are to supervise the quality of centrally authorised medicinal products placed on the market and to check compliance of these with their authorised specifications.
Danish: Formålet med programmet for stikprøveudtagning og afprøvning, der er baseret på lovfæstede krav, er at sikre det fornødne tilsyn med kvaliteten af centralt godkendte lægemidler på markedet og kontrollere, at de svarer til specifikationerne.