FrancophonIA/ELRC3.0 huggingface dataset:
English: Several medicinal products already authorised through the centralised procedure for cancer treatment had their indications extended to include new treatment options for patients suffering from breast cancer, ovarian cancer or (non-small cell) lung cancer.
Danish: Flere lægemidler, der i forvejen via den centraliserede procedure var godkendt til behandling af cancer, fik indikationerne udvidet til at omfatte nye behandlingsmuligheder for patienter med brystcancer, ovariecancer eller (ikke-småcellet) lungecancer.
English: For enquiries concerning VAMF certificates:
Danish: Forespørgsler om VAMF-certifikater:
English: 4.3 Sampling and testing
Danish: 4.3 Stikprøveudtagning og afprøvning
English: It held a public consultation exercise relating to the EMEA Road Map to 2010 discussion paper and a consultation on recommendations for better provision of information to patients.
Danish: Det afholdt en offentlig høring om et oplæg vedrørende "EMEA-køreplanen frem til 2010" samt en høring om, hvordan man sikrer patienter bedre information.
English: facilitating innovation and stimulating research, hence contributing to the competitiveness of EU-based pharmaceutical industry, and mobilising and coordinating scientific resources from throughout the EU to provide high-quality evaluation of medicinal products, to advise on research and development programmes, to perform inspections for ensuring fundamental GXP provisions are consistently achieved, and to provide useful and clear information to users and healthcare professionals.
Danish: at fremme innovation og stimulere forskningen og dermed bidrage til at styrke konkurrenceevnen hos EU's lægemiddelindustri, og at mobilisere og koordinere de videnskabelige ressourcer i hele EU for at sikre den mest pålidelige vurdering af lægemidler, at rådgive om forsknings- og udviklingsprogrammer, at foretage inspektioner for at sikre fuld overholdelse af de grundliggende GXP-bestemmelser, og at give brugere og fagfolk i sundhedssektoren relevante og klare informationer.
English: The procedure describes the coordination of GLP inspections of the nonclinical safety, toxicological and pharmacological studies proposed in human and veterinary applications for marketing authorisations under the centralised system.
Danish: Proceduren beskriver koordineringen af GLPinspektioner af den ikke-kliniske sikkerhed ved påtænkte toksikologiske og farmakologiske undersøgelser, hvortil der henvises i ansøgninger om markedsføringstilladelse for humanmedicinske lægemidler og veterinærlægemidler inden for det centraliserede system.
English: Per CLAESON (Sweden) Alternate: Ubonwan CLAESON
Danish: Per CLAESON (Sverige) suppleant: Ubonwan CLAESON
English: • Applications for medicinal products under development for the treatment of rare diseases to be designated as orphans increased again in number.
Danish: • Antallet af ansøgninger om at få lægemidler under udvikling til behandling af sjældne sygdomme betegnet som lægemidler til sjældne sygdomme steg atter.
English: The other safety review related to the class of COX-2 inhibitor medicines.
Danish: Den anden sikkerhedsundersøgelse vedrørte klassen af lægemidler med COX-2-hæmmere.
English: The authorisation holder is required to notify the EMEA of any defect or abnormal restriction of a centrally authorised medicinal product that could result in a recall.
Danish: Den pågældende skal underrette EMEA om enhver fejl eller unormal begrænsning ved et centralt godkendt lægemiddel, der vil kunne medføre tilbagekaldelse af produktet.
English: Gunar ALVÁN (Alternate: Anders BROSTRÖM) United Kingdom Kent WOODS (Alternate: Steve DEAN)
Danish: Gunar ALVÁN (suppleant: Anders BROSTRÖM) Det Forenede Kongerige Kent WOODS (suppleant: Steve DEAN)
English: Delegates and meetings
Danish: Delegerede og møder
English: Documentum, the electronic document management system, was successfully rolled out throughout the Agency during 2004.
Danish: Agenturets elektroniske dokumentstyringssystem, Documentum, blev indført med godt resultat i alle dele af agenturet i løbet af 2004.
English: Forty-one products were included within the scope of the programme of sampling and testing of centrally authorised products performed by the Network of Official Medicines Control Laboratories.
Danish: 41 produkter var omfattet af programmet for stikprøveudtagning og afprøvning af centralt godkendte produkter foretaget af netværket af statsanerkendte lægemiddellaboratorier.
English: • A new vaccine (the only one available) for active immunisation of dogs against Babesia canis and Babesia rossi to reduce severity of clinical signs associated with acute babesiosis and the anaemia that ensues following a heterologous challenge infection
Danish: • en ny vaccine (den eneste, der findes) til aktiv immunisering af hunde mod Babesia canis og Babesia rossi for at mildne de kliniske symptomer ved akut babesiosis og den efterfølgende anæmi, der skyldes en heterolog provokationsinfektion
English: This is a shortfall of 3 in comparison with the forecast of 10 MRL applications, and means the number remains at the same level as in 2003.
Danish: Det er tre færre end de forventede ti ansøgninger og betyder, at niveauet var det samme som i 2003.
English: • (Pre-)Clinical Working Party on Comparability of Biotechnology Products
Danish: • (Præ)klinisk arbejdsgruppe vedrørende bioteknologiprodukters sammenlignelighed
English: Requests for GMP inspection increased by 8 % relative to 2003, mainly due to a large number of reinspections which fell due and the impact of inspections in the context of the PMF certification scheme.
Danish: Antallet af anmodninger om GMP-inspektion steg med 8 % i forhold til 2003, hvilket primært skyldes, at tiden var inde til at foretage mange fornyede inspektioner, samt virkningen af inspektioner i forbindelse med PMF-certificeringsordningen.
English: • Reinforced role for the Agency in the provision of scientific advice to companies
Danish: • styrkelse af agenturets funktion i relation til videnskabelig rådgivning af virksomheder
English: The programme focuses primarily on important breakthrough drugs, and includes a mechanism for the EMEA, FDA and companies to exchange views on scientific issues during the development phase of new medicinal products.
Danish: Programmet fokuserer primært på vigtige innovative lægemidler og omfatter en procedure for udveksling af synspunkter mellem EMEA, FDA og virksomhederne i udviklingsfasen for nye lægemidler.
English: In line with its new responsibilities, the Board was consulted on the nominations for the Agency s Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP).
Danish: I tråd med de nye ansvarsområder blev bestyrelsen hørt i spørgsmålet om udpegelsen af medlemmer til agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) og Udvalget for Veterinærlægemidler (CVMP).
English: The EMEA checks compliance of such products distributed in parallel with the appropriate terms of the Community marketing authorisation.
Danish: EMEA kontrollerer, at produkter, der paralleldistribueres, overholder de gældende vilkår for EU-markedsføringstilladelsen.
English: Systems and procedures are fully in place for the timely back-up and archiving of the EMEA data
Danish: Systemer og procedurer for rettidig backup og arkivering af EMEA-data er indført i fuldt omfang
English: Emer COOKE (chair)
Danish: Emer COOKE (formand)
English: PAT is a system for designing, analysing and controlling manufacturing through the timely measurement (i.e. during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality (= identifying and monitoring factors that affect product quality).
Danish: PAT er et system til udvikling, analyse og kontrol af fremstillingsprocessen gennem tidlig måling (dvs. under selve processen) af kritiske kvalitetsmæssige egenskaber ved råvarerne, materialerne under forarbejdning og processerne med det formål at sikre kvaliteten af det endelige produkt).
English: • Approved nominations from Member States for new composition of the CHMP and CVMP
Danish: • godkendelse af medlemsstaternes indstillinger af nye medlemmer til CHMP og CVMP
English: EU institutions and regulatory authorities
Danish: EU-institutioner og regeludstedende myndigheder
English: Marketing authorisation holders may want to add new treatment options or introduce additional warnings or contraindications, or they may wish to change the manufacturing process.
Danish: Indehaveren af en markedsføringstilladelse vil måske gerne tilføje nye behandlingsmuligheder eller nye advarsler eller kontraindikationer eller eventuelt ændre fremstillingsprocessen.
English: Pharmacovigilance is a priority area for the EMEA, and its activities in this field include collecting and reviewing adverse drug reaction reports and periodic safety update reports, managing electronic collection and reporting systems, and issuing safety recommendations to healthcare professionals.
Danish: Lægemiddelovervågning er et prioriteret indsatsområde for EMEA, og aktiviteterne på dette felt omfatter indsamling og gennemgang af indberetninger af bivirkninger og periodiske opdaterede sikkerhedsindberetninger, forvaltning af elektroniske indsamlings- og indberetningssystemer samt udsendelse af sikkerhedsanbefalinger til fagfolk i sundhedssektoren.
English: • Adopted new policy on the handling of declarations of interests, and agreed to the publication of the declarations of interests of scientific committee members on the EMEA website
Danish: • vedtagelse af en ny politik for behandlingen af erklæringer om interesser og godkendelse af offentliggørelsen på EMEA's websted af disse erklæringer fra medlemmerne af de videnskabelige udvalg
English: A new referral procedure under Article 31 (Article 18 for centrally authorised products) was started for all COX-2 inhibitor medicines available in the EU in October 2004, due to concerns over cardiovascular safety.
Danish: I oktober 2004 indledtes en ny henvisningsprocedure i henhold til artikel 31 (artikel 18 for centralt godkendte produkter) omfattende alle lægemidler med COX-2-hæmmere på markedet i EU på baggrund af problemer med den kardiovaskulære sikkerhed.
English: As a consequence of the increasing number of centrally authorised products, the number of applications for variations to marketing authorisations increased once more in 2004.
Danish: I konsekvens af det stigende antal centralt godkendte produkter steg antallet af ændringsansøgninger atter i 2004.
English: The composition of the CHMP was announced on 1 June 2004, following the conclusion of a Management Board consultation procedure.
Danish: CHMP's sammensætning blev offentliggjort den 1. juni 2004 efter at være blevet forelagt for bestyrelsen.
English: Official batch release excluded
Danish: Ikke omfattet: officiel batchfrigivelse
English: 1 This figure refers to all reports received either on paper or electronically by the Agency.
Danish: 1 Tallet omfatter samtlige modtagne indberetninger, såvel elektroniske som i papirformat.
English: Annex 1 Members of the Management Board
Danish: Bilag 1 Medlemmer af bestyrelsen
English: • Work continued on the development of a regulatory and scientific environment for emerging and new technologies and therapies, and on contributing to new areas of legislation to address products for paediatric use, tissue engineered products and other public health areas such as influenza pandemic preparedness.
Danish: • Der blev fortsat arbejdet på at få udarbejdet et forskriftsmæssigt og videnskabeligt grundlag for vurderingen af nye teknologier og behandlingsformer og bidrage til lovgivningen på nye områder såsom pædiatriske lægemidler, produkter baseret på vævsteknik og andre emner af relevans for folkesundheden, f.eks. beredskabet over for influenzapandemier.
English: The EMEA provides companies with scientific advice on specific questions relating to the quality, safety or efficacy of their medicinal products.
Danish: EMEA kan rådgive virksomheder i specifikke spørgsmål vedrørende sikkerheden ved og kvaliteten og virkningerne af deres lægemidler.
English: A total of 108 applications for orphan product designation were received in 2004, which is a 24 % increase compared to the 87 received in 2003.
Danish: Der indkom i alt 108 ansøgninger om udpegelse af lægemidler til sjældne sygdomme i 2004, hvilket er 24 % flere end i 2003 (87).
English: Often, such guidelines are developed as a result of the EU s cooperation with Japan, the US and other international partners on the harmonisation of regulatory requirements for medicinal products, particularly through the International Conference on Harmonisation (ICH), and thus reflect a harmonised approach.
Danish: I mange tilfælde udarbejdes sådanne retningslinjer som et resultat af EU's samarbejde med Japan, USA og andre internationale partnere om harmonisering af lovfæstede krav til lægemidler, bl.a. via den internationale harmoniseringskonference (ICH), og er således udtryk for en harmoniseret strategi.
English: Following a decision of the Management Board in 2003, a 12-month pilot project was launched, in May 2004, to grant free scientific advice to any sponsor seeking to develop veterinary medicinal products for food-producing animals that fall under the minor uses and minor species scheme.
Danish: I maj 2004 blev der i overensstemmelse med en beslutning truffet af bestyrelsen i 2003 iværksat et tolv måneders pilotprojekt om gratis videnskabelig rådgivning til alle sponsorer, der ønsker at udvikle veterinærlægemidler til dyr, hvis produkter anvendes til menneskeføde, såfremt de pågældende lægemidler er omfattet af ordningen for lægemidler til mindre udbredte sygdomme og mindre arter.
English: Personnel
Danish: Personale
English: The EMEA participated in all meetings of the Heads of Medicines Agencies organised during the Irish and Dutch EU presidencies in 2004.
Danish: EMEA deltog i samtlige møder for styrelsescheferne under det irske og det nederlandske formandskab i 2004.
English: Initiatives undertaken in 2004 mainly related to the areas of risk identification and risk evaluation: in the field of risk identification through the further development and implementation of EudraVigilance; in the area of risk assessment by looking at a more proactive conduct of pharmacovigilance.
Danish: Initiativerne i 2004 vedrørte primært risikoafdækning og risikovurdering: førstnævnte område er blevet styrket gennem videreudviklingen og implementeringen af EudraVigilance og sidstnævnte område gennem en mere proaktiv indsats inden for lægemiddelovervågning.
English: To maintain the highest levels of security and confidentiality for all data held on EMEA systems
Danish: Opretholdelse af det højeste sikkerhedsniveau og fuld fortrolig behandling af alle data i EMEA's systemer
English: The programme of internal audits continued in 2004, including audits of the Committee for Medicinal Products for Human Use, the Committee for Medicinal Products for Veterinary Use and the Committee on Orphan Medicinal Products.
Danish: Programmet for interne revisioner fortsatte i 2004 og omfattede revision af Udvalget for Humanmedicinske Lægemidler, Udvalget for Veterinærlægemidler og Udvalget for Lægemidler til Sjældne Sygdomme.
English: There were no negative opinions given in 2004.
Danish: Der blev ikke afgivet negative udtalelser i 2004.
English: The EMEA receives safety reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
Danish: EMEA modtager både EU-interne og EU-eksterne sikkerhedsindberetninger, som vedrører lægemidler godkendt efter den centraliserede procedure, og koordinerer indsatsen for lægemidlers sikkerhed og kvalitet.
English: In a year which saw the adoption of four important new pieces of EU pharmaceutical legislation as well as the single biggest expansion of the European Union in its history, the year 2004 was one characterised by change.
Danish: 2004 - et år, hvor der blev vedtaget fire vigtige EU-retsakter på lægemiddelområdet, og EU oplevede sin største udvidelse nogensinde - stod i forandringens tegn.
English: The Committee held 11 plenary meetings in 2004.
Danish: Udvalget afholdt 11 plenarmøder i 2004.
English: In 2004, the EMEA and the CVMP, together with the Heads of Medicines Agencies Veterinary, started the European surveillance strategy an initiative intended to foster collaboration and support between Member States on the conduct of good pharmacovigilance practices.
Danish: EMEA og CVMP lancerede i 2004 sammen med styrelsescheferne for veterinærlægemidler den europæiske overvågningsstrategi - et initiativ, der skal fremme samarbejdet og den gensidige støtte mellem medlemsstaterne omkring god praksis for lægemiddelovervågning.
English: The referral was initiated to investigate concerns regarding user safety, in the interest of the Community, following an accidental human fatality resulting from use of this product during the treatment of animals earlier in 2004.
Danish: Sagen blev indbragt for at få undersøgt en mulig risiko for brugerne i hele EU's interesse efter et dødsfald, som angiveligt skyldtes, at den pågældende person havde anvendt produktet til behandling af dyr tidligere i 2004.
English: As part of this, the Board and committees agreed to the publication of the declarations of interests of the members of the Agency s scientific committees on the EMEA website.
Danish: Som led heri indvilgede bestyrelsen og udvalgene i at offentliggøre erklæringerne fra medlemmerne af agenturets videnskabelige udvalg om eventuelle interesser i lægemiddelsektoren på EMEA's websted.
English: • Domenica TARUSCIO (Italy)
Danish: • Domenica TARUSCIO (Italien)
English: 6.3 Meeting management and conferences
Danish: 6.3 Mødestyring og konferencer
English: Other medicinal products were approved for use in combination with other chemotherapy to treat metastatic breast cancer, non-Hodgkins lymphoma and metastatic prostate cancer.
Danish: Andre lægemidler blev godkendt til brug i kombination med anden kemoterapi til behandling af metastaseret brystcancer, non-Hodgkins lymphoma og metastaseret prostatacancer.
English: It will help to harmonise procedures and provisions concerning herbal medicinal products laid down in the Member States and help to further integrate herbal medicinal products in the European regulatory framework.
Danish: Det skal bistå med at harmonisere medlemsstaternes procedurer og bestemmelser i relation til plantelægemidler og medvirke til, at plantelægemidler i højere grad bliver omfattet af EU-lovgivningen.
English: The Board elected Hannes Wahlroos as its chairman and re-elected Jytte Lyngvig as vice-chairman.
Danish: Bestyrelsen valgte Hannes Wahlroos til formand og genvalgte Jytte Lyngvig til næstformand.
English: An overarching guideline on the general principle was issued for consultation in November 2004, along with concept papers on the requirements for different types of products.
Danish: I november 2004 blev der med henblik på en høring offentliggjort overordnede retningslinjer samt foreløbige oplæg om kravene til forskellige typer produkter.
English: • Emmanuel HÉRON (France)
Danish: • Emmanuel HÉRON (Frankrig)
English: During 2004, the EMEA participated in all meetings of the Commission s Pharmaceutical Committees for human and veterinary medicines and of the working groups established by the Pharmaceutical Committees.
Danish: EMEA deltog i 2004 i samtlige møder i Kommissionens udvalg for henholdsvis human- og veterinærmedicinske lægemidler og møderne i arbejdsgrupperne under disse udvalg.
English: • Margarita ARBOIX (Spain) Alternate: Ricardo de la FUENTE LÓPEZ
Danish: • Margarita ARBOIX (Spanien) suppleant: Ricardo de la FUENTE LÓPEZ
English: Predictions for 2005-2006 indicate a relatively stable level of applications.
Danish: Tallene for 20052006 forventes at være nogenlunde uændrede.
English: The EMEA s Mission Statement is, in the context of a continuing globalisation, to protect and promote public and animal health by developing efficient and transparent procedures to allow rapid access by users to safe and effective innovative medicines and to generic and non-prescription medicines through a single European marketing authorisation,
Danish: Det er EMEA's erklærede mål på baggrund af den fortsatte globalisering at beskytte og fremme folkesundheden og dyrs sundhed ved at udarbejde effektive og åbne procedurer, der giver brugerne hurtig adgang til sikre og effektive innovative lægemidler, generiske lægemidler og håndkøbsmedicin på grundlag af én fælles europæisk markedsføringstilladelse for hvert produkt,
English: Medical information
Danish: Medicinske oplysninger
English: Emiel VAN GALEN (Netherlands) Alternate: Burt H KROES
Danish: Emiel VAN GALEN (Nederlandene) suppleant: Burt H KROES
English: There was a shortfall of 3 applications from the 11 forecast for the year.
Danish: Der indkom 3 ansøgninger færre end de forventede 11 for hele året.
English: The dedicated range of services provided to EMEA staff, delegates and users of EU telematics systems from the applications themselves to the three levels of helpdesk support services ensure these systems are in line with the Agency s operating requirements
Danish: De specielle tjenester, EMEA's ansatte, delegerede og brugere af EUtelematiksystemer kan benytte, lige fra applikationerne til de tre niveauer af helpdesk-tjenester, sikrer, at disse systemer imødekommer agenturets driftsmæssige behov
English: These reports provide updates on the development of designated orphan products prior to submission of an application for a marketing authorisation.
Danish: Disse rapporter giver ajourførte oplysninger om udviklingen af lægemidler til sjældne sygdomme, før der indgives ansøgning om markedsføringstilladelse.
English: Working parties and ad hoc groups Ad hoc Meeting of GMP Inspection Services
Danish: Arbejdsgrupper og ad hoc-grupper Ad hoc-møde for GMP-inspektionstjenester
English: The Veterinary Mutual Recognition Facilitation Group (VMRFG) met at the EMEA every month (except August) in 2004, under the chairmanship of the Irish and Dutch EU presidencies.
Danish: Den veterinærmedicinske gruppe for fremme af gensidig anerkendelse (VMRFG) mødtes i 2004 hos EMEA under ledelse af henholdsvis det irske og det nederlandske formandskab.
English: The EMEA chaired and organised 4 meetings each for the Ad hoc GMP and GCP Inspectors Groups in 2004.
Danish: EMEA tilrettelagde og ledede fire møder i 2004 for både ad hoc-gruppen af GMP-inspektører og ad hoc-gruppen af GCP-inspektører.
English: Activities in the administration area relate to a number of functions, including managing and administering staff and seconded personnel, conducting recruitment procedures, and managing revenue, expenditure and accounts according to existing rules and regulations, as well as providing and running the necessary infrastructure services for effective functioning of the Agency.
Danish: Aktiviteterne på administrationsområdet vedrører en række funktioner, som omfatter personalestyring og -administration, administration af udlånt personale, gennemførelse af ansættelsesprocedurer, indtægts- og udgiftsstyring og regnskaber i overensstemmelse med eksisterende regler og forskrifter, samt tilvejebringelse og drift af de infrastrukturtjenester, der skal sikre, at agenturet fungerer effektivt.
English: Inspections of blood establishments to support certification of PMFs were initiated in the second half of 2004 and a total of 15 inspections were carried out in this context, involving 27 blood establishment sites.
Danish: I anden halvdel af 2004 begyndte man at inspicere blodbanker i forbindelse med PMF-certificeringen, og der blev gennemført i alt 15 sådanne inspektioner omfattende 27 blodbanker.
English: Significant line extension applications approved in 2004 to include child populations
Danish: Ansøgninger om væsentlige produktserieudvidelser godkendt i 2004 til at omfatte anvendelse til børn
English: The Mutual Recognition Facilitation Group (MRFG) reports to the Heads of Medicines Agencies Human.
Danish: Gruppen for fremme af gensidig anerkendelse (MRFG) refererer til styrelsescheferne for humanmedicinske lægemidler.