FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of meetings and meeting days increased by 24 % compared to the previous year, including extraordinary Management Board and CHMP meetings in May and September respectively, as well as new Committee on Herbal Medicinal Products (HMPC) meetings from September 2004 onwards.
Danish: Heri er medregnet ekstraordinære bestyrelsesmøder og CHMP-møder i henholdsvis maj og september og møder i det nye Udvalg for Plantelægemidler (HMPC) fra september 2004.
English: By the end of 2004, the following standing working parties supported the work of the CHMP:
Danish: Ved udgangen af 2004 havde CHMP følgende stående arbejdsgrupper:
English: 2.3 Initial evaluation
Danish: 2.3 Indledende vurdering
English: Brigitte BATLINER (Alternate: Peter MALIN)
Danish: Brigitte BATLINER (suppleant: Peter MALIN)
English: A systematic in-house peer-review system was also developed to help ensure a high level of continuity, consistency and quality of finalised SA/PA letters adopted by the CHMP.
Danish: Der blev desuden indført systematiske interne "peer-reviews" for at sikre kontinuitet, konsekvens og kvalitet i CHMP's endelige besvarelser af anmodninger om rådgivning eller protokolbistand.
English: A new procedure for requesting and reporting GLP inspections for centralised applications came into effect on 15 August 2004.
Danish: Den 15. august 2004 trådte en ny procedure for anmodning om GLP-inspektioner og rapportering af resultaterne i kraft for centralt godkendte lægemidler.
English: Three of the orphan product designation applications received in 2004 were from sponsors established in the new Member States.
Danish: Tre af ansøgningerne i 2004 om udpegelse af lægemidler til sjældne sygdomme kom fra sponsorer med hjemsted i de nye medlemsstater.
English: Altrenogest received a positive opinion to establish final MRLs in June 2004.
Danish: I juni 2004 blev der afgivet en positiv udtalelse om altrenogest med fastsættelse af endelige maksimale grænseværdier.
English: Head of Sector for regulatory affairs and organisational support
Danish: Sektionsleder - retsforskrifter og organisatorisk støtte
English: Assistance with translation of the indication and active substance name is offered to those SMEs which encounter difficulties in doing so themselves.
Danish: EMEA yder særlig støtte til små og mellemstore virksomheder (SMV), som tilbydes hjælp med oversættelsen af beskrivelsen af den sjældne lidelse og betegnelsen på det aktive stof, hvis de har problemer med selv at klare det.
English: VETERINARY MEDICINES AND INSPECTIONS
Danish: VETERINÆRMEDICINSKE LÆGEMIDLER OG INSPEKTIONER
English: See Annex 2 for information on working parties and scientific advisory groups.
Danish: Bilag 2 indeholder oplysninger om arbejdsgrupper og videnskabelige rådgivende grupper.
English: • Approved a proposal to publish the name of active substances, orphan condition and name of sponsor for all designated orphan drugs submitted for marketing authorisation
Danish: • godkendelse af forslag om at offentliggøre betegnelserne for de aktive stoffer, kriterierne og navnet på sponsoren for alle lægemidler, hvortil der ansøges om markedsføringsgodkendelse som lægemidler til sjældne sygdomme
English: 3.2 Initial evaluation
Danish: 3.2 Indledende vurdering
English: emtricitabine + tenofovir disoproxil fumarate !
Danish: Truvada emtricitabine + tenofovir disoproxil fumarate Part B
English: In the anti-HIV area, several variations were implemented in 2004 to add important safety information to relevant SPCs.
Danish: Der blev i 2004 gennemført flere ændringer men hensyn til behandling af hiv for at føje vigtige sikkerhedsoplysninger til de relevante produktresumeer.
English: IT training was provided to all EMEA staff on a regular basis.
Danish: Alle EMEA's ansatte fik systematisk ITundervisning.
English: Following the paroxetine referral, the Committee conducted a review of data available for the whole class of SSRI (serotonin selective reuptake inhibitor) and SNRI (serotonin-norepinephrine reuptake inhibitor) products at the request of the European Commission.
Danish: Efter henvisningssagen om paroxetin gennemgik udvalget efter anmodning fra Kommissionen alle disponible data for hele klassen af SSRI- (selektive serotiningenoptagelseshæmmere) og SNRI
English: • Metoda LIPNIK-STANGELJ (Slovenia) Alternate: Barbara RAZINGER-MIHOVEC
Danish: • Metoda LIPNIK-STANGELJ (Slovenien) suppleant: Barbara RAZINGER-MIHOVEC
English: Out of hours telephone: (44-7880) 55 06 97
Danish: Tlf. uden for arbejdstiden: (44-7880) 55 06 97
English: • Kenneth MIFSUD (Malta) Alternate: Joseph VELLA
Danish: • Kenneth MIFSUD (Malta) suppleant: Joseph VELLA
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2005 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tlf. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@EMEA.eu.int http://www.EMEA.eu.int©EMEA 2005 Gengivelse og/eller distribution af dette dokument til ikke-kommercielle formål er tilladt med kildeangivelse
English: Average time for orphan medicines procedures (days)
Danish: Gennemsnitlig varighed af procedurer for lægemidler til sjældne sygdomme (dage)
English: The certificates also confirm the Good Manufacturing Practice (GMP) compliance status of the manufacturing site(s) producing the medicinal product bulk pharmaceutical form.
Danish: Certifikatet bekræfter desuden, at de(n) virksomhed(er), der massefremstiller lægemidler, overholder reglerne for god fremstillingspraksis (GMP).
English: • Sif ORMARSDÓTTIR (Iceland) Alternate: Magnús JÓHANNSSON
Danish: • Sif ORMARSDÓTTIR (Island) suppleant: Magnús JÓHANNSSON
English: Implementation of the plan, which also considered the impact of the EU enlargement in May 2004 and the need to prepare for future revisions of pharmaceutical legislation, started in early 2004.
Danish: Gennemførelsen af planen, der også tog højde for virkningerne af EU's udvidelse i maj 2004, blev påbegyndt i starten af 2004.
English: Steffen BAGER (Denmark) Alternate: Kristine HVOLBY
Danish: Steffen BAGER (Danmark) suppleant: Kristine HVOLBY
English: Scientific guidance
Danish: Videnskabelige retningslinjer
English: Major tasks of the HMPC: preparatory work for the establishment of a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products; the elaboration of Community herbal monographs for herbal medicinal products with a well-established use and for traditional herbal medicinal products.
Danish: HMPC's vigtigste opgaver bliver at forberede udarbejdelsen af et udkast til fortegnelse over plantestoffer og præparater og blandinger heraf til anvendelse i traditionelle plantelægemidler og at udarbejde EU-plantemonografier for plantelægemidler med veldokumenteret anvendelse samt traditionelle plantelægemidler.
English: The role of this group is to advise the CVMP on specific scientific questions addressed to it.
Danish: Denne gruppe skal rådgive CVMP i specifikke videnskabelige spørgsmål, udvalget får forelagt.
English: Five applications for extension to the original marketing authorisation were received in 2004, exceeding the initial forecast of 3 applications.
Danish: I 2004 indkom der fem ansøgninger om udvidelse af den oprindelige markedsføringstilladelse, hvilket var tre mere end forventet.
English: COMP designation opinions EC designation decisions
Danish: COMP's udtalelser om udpegelse EF's afgørelser om udpegelse
English: • Arvils JAKOVSKIS (Latvia)
Danish: • Arvils JAKOVSKIS (Letland)
English: • Nikolaos DRAKOULIS (Greece) Alternate: Michalis AVGERINOS
Danish: • Nikolaos DRAKOULIS (Grækenland) suppleant: Michalis AVGERINOS
English: 9 Replaced Helen VELLA as of July 2004 meeting.
Danish: 9 Trådte i stedet for Helen VELLA fra juli 2004.
English: 2 Replaced George SHORTEN as of December 2004 meeting.
Danish: 2 Trådte i stedet for George SHORTEN fra december
English: Creation of scientific advisory groups
Danish: Nedsættelse af videnskabelige rådgivende grupper
English: 1 The EMEA Herbal Medicinal Products Working Party (HMPWP) was succeeded by the Committee on Herbal Medicinal Products (HMPC).
Danish: 1 EMEA's arbejdsgruppe vedrørende plantelægemidler (HMPWP) blev erstattet af Udvalget for Plantelægemidler (HMPC).
English: In 2004, the number of presubmission meetings held for scientific advice procedures was 40, with a further 20 pre-submission meetings held for protocol assistance procedures.
Danish: I 2004 afholdtes 40 sådanne forberedende møder med henblik på videnskabelig rådgivning og 20 forberedende møder vedrørende protokolbistand.
English: Health Canada initiated assessments of Hungary and the Czech Republic following successful preMRA visits coordinated by the Commission as part of the extension of the MRA to cover new Member States.
Danish: Health Canada indledte bedømmelser af Ungarn og Tjekkiet efter en række positive besøg forud for aftalens indgåelse.
English: • Provision for the CHMP to give scientific opinions in the context of cooperation with the WHO for the use of medicines outside the EU
Danish: • mulighed for, at CHMP kan afgive videnskabelige udtalelser i forbindelse med samarbejdet med WHO vedrørende brugen af lægemidler uden for EU.
English: 10 June 2004
Danish: 10. juni 2004
English: Annex 11
Danish: Bilag 11
English: Feline leukaemia
Danish: Cats Feline leukaemia
English: Inspections
Danish: Inspektioner
English: Establishment of maximum residue limits for new substances
Danish: Fastsættelse af maksimale grænseværdier for restkoncentrationer af nye stoffer
English: Joint CHMP/CVMP Quality Working Party Chair: Jean-Louis ROBERT EMEA contact: Emer COOKE
Danish: Fælles CHMP/CVMP-arbejdsgruppe vedrørende kvalitet Formand: Jean-Louis ROBERT EMEA-kontakt: Emer COOKE
English: 2 Replaced Manfred HAASE as of September 2004 meeting.
Danish: 2 Trådte i stedet for Manfred HAASE fra sept. 2004.
English: All variation procedures were handled within the legal timeframes.
Danish: Alle ansøgninger om ændringer blev behandlet inden for de lovfæstede tidsfrister.
English: 3.5 Post-authorisation activities
Danish: 3.5 Aktiviteter efter godkendelse
English: See Annex 10 for a detailed list of opinions adopted.
Danish: Bilag 10 indeholder en fuldstændig fortegnelse over de vedtagne udtalelser.
English: In its strategic action plan detailed in the paper, the Agency and Committee are exploring such possibilities as provisional authorisations, adaptation of data requirements, further possibilities for extrapolation of MRLs, and the provision of assistance by the Agency to companies wanting to authorise such products.
Danish: I forbindelse med den strategiplan, der er beskrevet i dokumentet, udforsker agenturet og udvalget forskellige muligheder som f.eks. foreløbige godkendelser, tilpasning af datakravene, øgede muligheder for at ekstrapolere
English: Members • Eric ABADIE (EMEA representative)
Danish: • Eric ABADIE (EMEA-repræsentant)
English: • Biotechnology Working Party
Danish: • Arbejdsgruppen vedrørende bioteknologi
English: Good clinical practice (GCP) activities
Danish: God klinisk praksis (GCP)
English: Information on USRs can be found on the EMEA website at: http://www.emea.eu.int/htms/human/drugalert/drugalert.htm
Danish: Yderligere oplysninger om sikkerhedsbegrænsninger findes på EMEA's websted på: http://www.EMEA.eu.int/htms/human/drugalert/drugalert.htm
English: The annual report for 2004 is presented to the Management Board by the Executive Director in accordance with Article 64(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
Danish: Årsberetningen for 2004 forelægges bestyrelsen af den administrerende direktør i overensstemmelse med artikel 64, stk. 3, i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 af 31. marts 2004 om fastlæggelse af fællesskabsprocedurer for godkendelse og overvågning af human- og veterinærmedicinske lægemidler og om oprettelse af et europæisk lægemiddelagentur.
English: Number of inspections 2002-2004
Danish: Antal inspektioner 2002-2004
English: • An equine vaccine for immunisation against Streptococcus equi for the condition of strangles a most debilitating disease that affects horses, characterised by high fever, coughing and difficulty in swallowing due to swelling of the mandibular lymph nodes
Danish: • en vaccine til heste til immunisering mod Streptococcus equi, der kan forårsage sygdommen kværke - en særdeles alvorlig sygdom hos heste, der er karakteriseret ved høj feber, hoste og synkeproblemer på grund af hævede lymfekirtler i kæben
English: • Despite initial delays, the preparatory work for effective operation of the Japan-EU mutual recognition agreement (MRA) was successfully concluded, allowing the operational phase of the agreement to come into force on 29 May 2004.
Danish: • Det forberedende arbejde forud for indgåelsen af aftalen mellem EU og Japan om gensidig anerkendelse (MRA) blev afsluttet med godt resultat på trods af forsinkelser i starten, og aftalen trådte i kraft i fuldt omfang den 29. maj 2004.
English: Mutual recognition agreement (MRA) implementation status and coverage
Danish: Gensidige anerkendelsesaftaler - status over gennemførelsen samt anvendelsesområde
English: Arbitration and Community referrals 1995-2004
Danish: Voldgiftssager og henvisningssager 1995-2004
English: Meeting management and conferences
Danish: Mødestyring og konferencer
English: The objective of introducing greater consistency in the triggering of investigations following receipt of pharmacovigilance reporting has been progressed by the release for consultation of a guideline by the CVMP on this topic in June 2004.
Danish: Målsætningen om at skabe mere ensartede vilkår for igangsætning af undersøgelser efter indberetning af bivirkninger er kommet nærmere sin opfyldelse, efter at CVMP i juni 2004 sendte retningslinjer herfor til høring.
English: European Community Canada
Danish: EU-Canada
English: Number of reimbursed meetings Number of reimbursed delegates
Danish: Møder med godtgørelse Delegerede, der modtog godtgørelse
English: It has an advisory function for integrated quality management at the Agency.
Danish: Den har en rådgivende funktion for agenturets integrerede kvalitetsstyring og er desuden ansvarlig for agenturets risikostyring.
English: 11 March 2004
Danish: 11. marts 2004
English: The work of the CHMP is supported by a number of working parties, composed of European experts selected from a list maintained by the EMEA.
Danish: CHMP bistås i sit arbejde af arbejdsgrupper bestående af europæiske eksperter valgt fra en liste, som EMEA fører.
English: Results requiring further investigation were found for 3 of the 31 products.
Danish: For 3 ud af de 31 gav resultaterne anledning til yderligere undersøgelser.
English: Safety and efficacy of medicines
Danish: Lægemidlers sikkerhed og virkning
English: In order to support initiatives promoting pharmacovigilance in the EU, with particular focus on providing support to the new Member States, a common reporting form for reporting suspected adverse reactions to veterinary medicinal products by veterinarians and other veterinary health professionals was developed by the CVMP Pharmacovigilance Working Party for use in all EU Member States, and was released for consultation by the CVMP in October 2004.
Danish: Med det formål at støtte initiativer til fremme af lægemiddelovervågningen i EU og med særlig fokus på at hjælpe de nye medlemsstater udviklede CVMP's arbejdsgruppe vedrørende lægemiddelovervågning en fælles indberetningsformular til indberetning fra dyrlæger og andre fagfolk i veterinærsektoren af formodede bivirkninger ved veterinærlægemidler.
English: These details include the name of the medicinal product, the orphan indication and the name of the sponsor.
Danish: Det drejer sig om navnet på lægemidlet, en beskrivelse af den sjældne lidelse og navnet på sponsoren.
English: Collection of human plasma for further manufacturing, as well as storage, testing and transportation, is subject to periodic inspections in order to ensure the expected product quality.
Danish: Der foretages regelmæssigt inspektion af indsamlingen af humant plasma til videreforarbejdning og af opbevaringen, testningen og transporten af materialet for at sikre den ønskede produktkvalitet.
English: The IT development team started work on the inception phase of this project with the Inspections TIG.
Danish: IT-udviklingsgruppen påbegyndte den indledende fase af dette projekt i samarbejde med telematikimplementeringsgruppen vedrørende inspektioner.
English: • Tibor SOÓS (Hungary) Alternate: Gábor KULCSÁR
Danish: • Tibor SOÓS (Ungarn) suppleant: Gábor KULCSÁR
English: • Adopted new financial regulation and implementing rules for the Agency
Danish: • vedtagelse af agenturets nye finansforordning med tilhørende gennemførelsesbestemmelser
English: In 2004, 8 (22 %) out of 37 applications for marketing authorisation that had an outcome in the centralised procedure received prior scientific advice.
Danish: I 2004 blev der ydet forudgående videnskabelig rådgivning i forbindelse med 8 (22 %) af 37 ansøgninger om markedsføringstilladelse, der blev færdigbehandlet efter den centraliserede procedure.
English: In light of the steady growth of the Agency, a new floor providing office space for EMEA staff was fitted out in 2004.
Danish: Som følge af agenturets fortsatte vækst blev der i 2004 indrettet en ny etage for at skaffe kontorlokaler til flere medarbejdere.
English: Implementation status
Danish: Status over gennemførelsen
English: Jytte LYNGVIG (vice-chairman) (Alternate: Paul SCHÜDER)
Danish: Jytte LYNGVIG (næstformand) (suppleant: Paul SCHÜDER)
English: See Annex 12 for full list of guidelines.
Danish: Bilag 12 indeholder en fuldstændig fortegnelse over sådanne retningslinjer.
English: • Marc WIRTOR (Luxembourg) Alternate: Maurice HOLPER
Danish: • Marc WIRTOR (Luxembourg) suppleant: Maurice HOLPER
English: In addition, the EMEA contributed to the work undertaken at the level of the Heads of Medicines Agencies on further development of the European Risk Management Strategy.
Danish: EMEA deltog også i det arbejde, styrelsescheferne har sat i gang om udbygning af den europæiske strategi for risikostyring.
English: Chair: Gérard MOULIN EMEA contact: Peter JONES Members
Danish: Formand: Gérard MOULIN EMEA-kontakt: Peter JONES Medlemmer
English: The fee reduction policy applicable to designated orphan medicinal products during 2004 remained unchanged since 2002 and was as follows:
Danish: Også i 2004 fulgte man den politik for gebyrnedsættelser for udpegede lægemidler til sjældne sygdomme, som har været gældende siden 2002:
English: In 2004, the number of pre-submission meetings held was 65.
Danish: I 2004 blev der afholdt 65 sådanne forudgående møder.
English: Zsuzsanna BIRÓ-SÁNDOR (Hungary) Alternate: Gyöngyi BACS
Danish: Zsuzsanna BIRÓ-SÁNDOR (Ungarn) suppleant: Gyöngyi BACS
English: Human and veterinary medicinal products
Danish: Human- og veterinærmedicinske lægemidler
English: EMEA contact: Spiros VAMVAKAS
Danish: EMEA-kontakt: Spiros VAMVAKAS
English: Impact of scientific advice
Danish: Effekten af den videnskabelige rådgivning
English: Activities in relation to new and emerging therapies
Danish: Aktiviteter vedrørende nye behandlingsformer
English: Centralised applications - Negative opinions
Danish: Ansøgninger efter den centraliserede procedure - Negative udtalelser
English: • Pharmacogenetics Working Party Four temporary working parties also supported the work of the CHMP:
Danish: Dertil kommer fire midlertidige arbejdsgrupper, som også bistod CHMP:
English: • Alfred HERA (Czech Republic) Alternate: Jiří BURE
Danish: • Alfred HERA (Tjekkiet) suppleant: Jiří BUREŠ
English: • The CHMP recommended a marketing authorisation for a monoclonal antibody that binds to the epidermal growth factor receptor associated with the growth of many cancers
Danish: • CHMP anbefalede godkendelse af et monoklonalt antistof, som hæmmer den epidermale vækstfaktorreceptor, der forbindes med mange cancerformers vækst.
English: Initial marketing authorisation applications per therapeutic area in 2004
Danish: Ansøgninger om første markedsføringstilladelse opgjort efter terapeutisk område - 2004
English: Anticoagulant in patients undergoing percutaneous coronary intervention (PCI)
Danish: B01A (pending) Anticoagulant in patients undergoing percutaneous coronary intervention (PCI)
English: Spiros VAMVAKAS (from midOctober 2004)
Danish: Spiros VAMVAKAS (fra medio oktober 2004)
English: Veterinary immunologicals and vaccines excluded
Danish: Ikke omfattet: immunologiske veterinærlægemidler og vacciner
English: Specific training on all aspects of Eudranet was given to Eudranet NCA delegates at the EMEA
Danish: De nationale Eudranet-delegerede gennemgik særlige kurser hos EMEA i alle aspekter af Eudranet.
English: • Algirdas UTKUS (Lithuania)
Danish: • Algirdas UTKUS (Litauen)
English: Implementation of the EU telematics strategy, administration and other support activities are described in Chapters 5 and 6.
Danish: Kapitel 5 og 6 omhandler henholdsvis gennemførelsen af EU's telematikstrategi og administration og andre støtteforanstaltninger.
English: 4 Replaced Daniel BRASSEUR as of June 2004 meeting.
Danish: 4 Trådte i stedet for Daniel BRASSEUR fra juni 2004.
English: Working Group with Patients' Organisations Chair: Frits LEKKERKERKER/Noël WATHION
Danish: EMEA/CHMP-arbejdsgruppen med deltagelse af patientorganisationer Formand: Frits LEKKERKERKER/Noël WATHION
English: To promote internal awareness of IT and training on EMEA-specific systems amongst EMEA staff and delegates
Danish: Bedre IT-kundskaber internt i EMEA og uddannelse af ansatte og delegerede i de særlige EMEA-systemer
English: Despite initial delays, the preparatory work for effective operation of the Japan-EU MRA was successfully concluded through a series of visits and inspections allowing the operational phase of the agreement to come into force on 29 May 2004.
Danish: Det forberedende arbejde med henblik på gennemførelsen i praksis af den gensidige anerkendelsesaftale mellem EU og Japan blev - på trods af forsinkelser i starten - afsluttet med en række besøg og inspektioner, der betød, at aftalen kunne træde endeligt i kraft den 29. maj 2004.
English: All working documents adopted by the HMPWP are listed in Annex 12.
Danish: Bilag 12 indeholder en fortegnelse over alle de arbejdsdokumenter, der er vedtaget af HMPWP.
English: Human Fibrinogen + Human Thrombin !
Danish: TachoSil Human Fibrinogen + Human Thrombin Part B
English: The EMEA PMF/VAMF certification process is an assessment of the PMF/VAMF application dossier.
Danish: Certificering af masterfilerne betyder, at EMEA foretager en vurdering af ansøgningsdossierne for PMF/VAMF.
English: European Community Japan
Danish: EU-Japan
English: The new sector is responsible for the provision of information that is easily understandable and accessible for patients and healthcare professionals.
Danish: Det er baggrunden for, at EMEA oprettede en ny sektion for medicinske oplysninger, som har ansvaret for at tilvejebringe let forståelige og tilgængelige informationer til patienter og fagfolk i sundhedssektoren.
English: Legal sector
Danish: Juridisk sektion
English: The development of a CVMP simple guide to veterinary pharmacovigilance in the EU was started in 2004, following consultation on a concept paper.
Danish: I 2004 indledtes arbejdet med udgivelse af en enkel CVMP-vejledning i overvågning af veterinærlægemidler i EU, efter at et oplæg havde været lagt ud til høring.
English: Salaries
Danish: Lønninger