FrancophonIA/ELRC3.0 huggingface dataset:
English: The proposals include revising the current framework of interaction between the Agency and patients' and consumers' organisations, and providing financial support by doubling the daily allowance in defined cases.
Danish: Forslagene omfattede en revision af de nuværende rammer for samarbejdet mellem agenturet og patient- og forbrugerorganisationer og tilvejebringelse af finansiel støtte ved at fordoble dagpengesatsen i nærmere fastsatte tilfælde.
English: Taking into consideration the outcomes of the pilot and the estimated impact on the Agency's budget, and in light of the observations made by the Court of Auditors and the European Commission, the Executive Director submitted for adoption a new remuneration system, based on the proposal presented in March and June 2008, which aims to align the remuneration system with the legislative requirements.
Danish: Under hensyntagen til resultaterne af pilotprojektet og den anslåede indvirkning på agenturets budget samt i lyset af Revisionsrettens og Europa-Kommissionens bemærkninger fremlagde den administrerende direktør med henblik på vedtagelse et nyt betalingssystem, som var baseret på det forslag, der var blevet fremlagt i marts og juni 2008, og som tog sigte på at tilpasse betalingssystemet til lovkravene.
English: Members suggested engaging with the European Court of Auditors to explain the Board's concern and the benefits of the existing system.
Danish: Medlemmerne foreslog, at man tog kontakt til Den Europæiske Revisionsret for at forklare bestyrelsens betænkeligheder og fordelene ved det nuværende system.
English: The European Commission representative informed that the Commission has recently adopted the text of the vacancy notice and the grade AD14.
Danish: Europa-Kommissionens repræsentant oplyste, at Kommissionen for nylig havde vedtaget stillingsopslagets tekst og løntrinnet AD14.
English: 10(a) Management Board Telematics Committee
Danish: 10(a) Bestyrelsens telematikudvalg
English: Topic coordinators (the Vice-chair, Austria, Denmark, the Netherlands, Sweden and Prof. Nisticó) provided positive feedback on the vision outlined in the draft road map.
Danish: Emnekoordinatorerne (næstformanden, Østrig, Danmark, Nederlandene, Sverige og prof. Nisticó) gav positiv tilbagemelding på den vision, der var skitseret i udkastet til køreplanen.
English: It is expected that the new structure will increase the overall efficiency of the Agency's operations, improve the quality of its work and increase the effectiveness of its interaction with stakeholders.
Danish: Det forventedes, at den nye struktur ville øge den generelle effektivitet af agenturets aktiviteter, forbedre kvaliteten af dets arbejde og øge effektiviteten af dets samarbejde med interessenterne.
English: A discussion on this topic will be planned during the March 2010 meeting.
Danish: Der ville blive planlagt en drøftelse af dette emne på mødet i marts 2010.
English: Members discussed the needs to understand the relevant positions of regulators and health-technology assessment bodies and to ensure that cost-benefit analysis does not become a part of the regulatory assessment of medicines.
Danish: Medlemmerne drøftede behovet for at forstå de relevante holdninger hos lovgivere og sundhedsteknologivurderingsorganer og sikre, at costbenefitanalyser ikke blev en del af overensstemmelsesvurderingen af lægemidler.
English: Revised reimbursement rules for delegates
Danish: Reviderede godtgørelsesregler for delegerede
English: Report from the Heads of Medicines Agencies The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including: publication of information on e-readiness in each of the national competent authorities; the creation of the network of HMA contacts on medicines advertising; the veterinary SPC harmonisation project; and revision of the action plan in the field of antimicrobial resistance.
Danish: Rapport fra cheferne for de nationale lægemiddelstyrelser Medlemmerne noterede sig den ajourførte rapport fra cheferne for de nationale lægemiddelstyrelser (HMA) om en lang række emner: Offentliggørelse af oplysninger om e-parathed hos hver af de nationale kompetente myndigheder, etablering af et netværk af HMA-kontakter vedrørende lægemiddelreklamer, projektet til harmonisering af produktresuméer for veterinærlægemidler og revision af handlingsplanen inden for antimikrobiel resistens.
English: EU telematics master plan
Danish: EU's masterplan for telematik
English: The Board discussed the need to consider options for addressing the gap between the workload and the number of temporary agents.
Danish: Bestyrelsen drøftede behovet for at overveje løsninger med henblik på at afhjælpe misforholdet mellem arbejdsbyrden og antallet af midlertidigt ansatte.
English: The Committee will meet the chairs of all of the telematics implementation groups ahead of the next Management Board meeting.
Danish: Udvalget ville afholde møde med formændene for alle telematikimplementeringsgrupperne forud for det næste bestyrelsesmøde.
English: The Agency is completing the development of an entirely new public website that offers muchimproved content structure, user-friendliness and functionality for the Agency's audiences.
Danish: Agenturet var ved at færdiggøre udviklingen af et helt nyt offentligt websted med en væsentlig bedre indholdsstruktur, brugervenlighed og funktionalitet for agenturets målgrupper.
English: London, 10 December 2009
Danish: London, den 10. december 2009
English: The Board stressed that the national competent authorities are an integral part of the EU network, and highlighted the future role of patients in decision-making in the course of the assessment of medicines.
Danish: Bestyrelsen understregede, at de nationale kompetente myndigheder var en integrerende del af EUnetværket, og fremhævede patienternes fremtidige rolle i beslutningstagningen i forbindelse med vurderingen af lægemidler.
English: • publication of the guidelines on variations;
Danish: • offentliggørelse af retningslinjerne vedrørende ændringer
English: • Presentation on the Road Map to 2015.
Danish: • Præsentation af køreplanen frem til 2015
English: Taking into account the recent change of responsibility for the Agency within the European Commission, the members asked to ensure that the road map takes into account DG Sanco's strategic directions.
Danish: På baggrund af den nylige ændring af ansvaret for agenturet inden for Europa-Kommissionen anmodede medlemmerne om at sikre, at køreplanen tog højde for GD Sancos strategiske retninger.
English: Those national competent authorities also showed that they are able to record the hours spent on centralised applications.
Danish: Disse nationale kompetente myndigheder viste også, at de var i stand til at registrere de timer, der var anvendt på ansøgninger indgivet via den centrale procedure.
English: The Board discussed the concern that a higher proportion of the telematics budget will be consumed by maintenance of the systems as more telematics systems come into operation over the years.
Danish: Bestyrelsen drøftede problemet med hensyn til, at en større andel af telematikbudgettet ville gå til at vedligeholde systemerne, efterhånden som der med tiden ville blive taget flere telematiksystemer i brug.
English: • progress on the two legal proposals (pharmacovigilance and falsified medicines legislation);
Danish: • fremskridt med to lovgivningsforslag (om lægemiddelovervågning og forfalskede lægemidler)
English: The publication of the notice is expected in the second week of January 2010.
Danish: Opslaget forventedes offentliggjort i anden uge af januar 2010.
English: Topic coordinators will meet to further elaborate their proposal.
Danish: Emnekoordinatorerne ville afholde et møde med henblik på at beskrive deres forslag nærmere.
English: The Management Board was informed that a confidentiality arrangement is under preparation with Switzerland.
Danish: Samarbejde med den schweiziske lægemiddelstyrelse Bestyrelsen blev informeret om, at en fortrolighedsaftale med Schweiz var under udarbejdelse.
English: 18 March 2010 EMA/MB/806136/2009
Danish: 18. marts 2010 EMA/440663/2011
English: • public consultation on the assessment of the functioning of the Clinical Trials Directive (closing date
Danish: • offentlig høring om vurderingen af anvendelsen af direktivet om kliniske forsøg (afsluttes den 8.
English: Alternates and other participants veterinarians' organisations Observers
Danish: Suppleanter og andre deltagere dyrlægeorganisationer Observatører
English: • focus on core business (including addressing the growing volume of activities in such areas as post-authorisation activities and orphan medicinal products);
Danish: • fokus på kerneaktiviteter (herunder fokus på det stigende antal aktiviteter på områder som aktiviteter efter godkendelse og lægemidler til sjældne sygdomme)
English: The report will in future also provide, for centrally authorised products for human use, information on signal management, from signal detection through to follow-up, including feedback provided by rapporteurs and any subsequent regulatory action taken.
Danish: Med hensyn til humanmedicinske lægemidler, som godkendes via den centrale procedure, ville rapporten i fremtiden også indeholde oplysninger om signalhåndtering, lige fra signaldetektering til opfølgning, herunder feedback fra rapportører og eventuelle efterfølgende reguleringstiltag.
English: • availability of medicines.
Danish: • adgang til lægemidler.
English: The meeting underlined that good coordination between the Management Board's and the Heads of Medicines Agencies' telematics committees is essential.
Danish: Det understregedes på mødet, at en god koordinering mellem telematikudvalgene under bestyrelsen og cheferne for de nationale lægemiddelstyrelser var af afgørende betydning.
English: • strengthening the European medicines network;
Danish: • styrkelse af det europæiske lægemiddelnetværk
English: − On consultation on changes in the membership of the CHMP and CVMP scientific committees;
Danish: Om høring vedrørende ændringer i medlemskabet af CHMP- og CVMP-udvalgene
English: 13bis.
Danish: 13a.
English: Representative of
Danish: Repræsentanter for
English: The meeting comes ahead of Mr Dalli's hearing at the European Parliament and the Agency's move from the responsibility of the Directorate-General Enterprise and Industry to the Directorate-General Health and Consumers.
Danish: Mødet kom forud for høringen af John Dalli i Europa-Parlamentet og flytningen af ansvaret for agenturet fra Generaldirektoratet for Erhvervspolitik til Generaldirektoratet for Sundhed og Forbrugere.
English: The development of the framework has taken longer then planned due to the need to meet two sets of views: those of academia and learned societies on one hand, and those of prescribing physicians and pharmacists on the other.
Danish: Det havde taget længere tid at udvikle rammerne end planlagt på grund af behovet for at imødekomme to sæt synspunkter, dvs. på den ene side synspunkterne blandt forskere og videnskabelige kredse og på den anden side synspunkterne blandt receptudstedende læger og farmaceuter.
English: The reduction is due to lower than requested Community contribution and reduced fee revenue estimates due to the impact of the new regulation on variations and a shift to non-fee or reduced-fee applications.
Danish: Nedsættelsen skyldtes et lavere tilskud fra Unionen og lavere anslåede gebyrindtægter som følge af virkningen af den nye forordning om ændringer og overgangen til ansøgninger, der var omfattet af gebyrfrihed eller gebyrnedsættelser.
English: Rannveig Gunnarsdóttir (Iceland) Gro Ramsten Wesenberg (Norway) Brigitte Batliner (Liechtenstein)
Danish: Rannveig Gunnarsdóttir (Island) Gro Ramsten Wesenberg (Norge) Brigitte Batliner (Liechtenstein)
English: The pilot concluded that the national competent authorities, which participated in the pilot, are in a position to identify their hourly rates for services provided.
Danish: Det konkluderedes i pilotprojektet, at de nationale kompetente myndigheder, der deltog i pilotprojektet, var i stand til at fastsætte deres timesatser for de leverede tjenester.
English: The budget topic coordinators (the Chair, Austria, Germany and the Netherlands) scrutinised the Agency's work programme and budget documents ahead of the Management Board, received responses to their questions and recommended that the Board adopt the documents.
Danish: Emnekoordinatorerne for budgettet (formanden, Østrig, Tyskland og Nederlandene) havde udførligt gennemgået agenturets arbejdsprogram og budgetdokumenterne inden bestyrelsen, modtaget svar på deres spørgsmål og anbefalet, at bestyrelsen vedtog dokumenterne.
English: • Draft terms of reference for the Management Board Telematics Committee.
Danish: • Udkast til kommissorium for bestyrelsens telematikudvalg.
English: In light of the earlier discussions on the grade level and in view of the Agency's move to the responsibility of DG Sanco, the Board enquired whether the publication could be delayed to allow the new Commissioner to express his views with regards to the grading of the Executive Director's post.
Danish: I lyset af de tidligere drøftelser om løntrinnet og i betragtning af flytningen af ansvaret for agenturet til GD Sanco forhørte bestyrelsen sig om, hvorvidt offentliggørelsen kunne udskydes, for at den nye kommissær kunne få mulighed for at udtale sig om løntrinnet for stillingen som administrerende direktør.
English: In view of changes within the European Commission of the responsibilities for the Agency, the Management Board expressed its thanks to Heinz Zourek, Director-General of DG Enterprise and Industry, for his significant contribution to the work of the Board and of the Agency.
Danish: I betragtning af ændringerne i Europa-Kommissionen med hensyn til, hvem der skulle have ansvaret for agenturet, takkede bestyrelsen Heinz Zourek, generaldirektøren for GD for Erhvervspolitik, for hans betydelige bidrag til bestyrelsens og agenturets arbejde.
English: Taking into account the mandate of the PhVWP, the proposal will now be put to the January 2010 HMA meeting for adoption.
Danish: Under hensyntagen til PhVWP's mandat ville forslaget nu blive forelagt cheferne for de nationale lægemiddelstyrelser til vedtagelse på mødet i januar 2010.
English: • [EMEA/MB/715154/2009] Outcome of written procedures:
Danish: • [EMEA/MB/715154/2009] Resultat af skriftlige procedurer:
English: Chair: Pat O'Mahony Vice-chair: Lisette Engwirda-Tiddens
Danish: Formand: Pat O'Mahony Næstformand: Lisette Engwirda-Tiddens
English: The Chair thanked the members for the work done during the interactions and correspondence with the European Commission with regard to the vacancy notice and the grading of the Executive Director's post.
Danish: Formanden takkede medlemmerne for arbejdet i forbindelse med samarbejdet og korrespondancen med Europa-Kommissionen med hensyn til stillingsopslaget og løntrinnet for stillingen som administrerende direktør.
English: The topic coordinators (the Chair, Austria and the Netherlands) proposed an alternative solution: to introduce, for a transitional period, a payment system based on Eurostat correction coefficients, and to continue collecting costing data for assessment of centralised applications.
Danish: Emnekoordinatorerne (formanden, Østrig og Nederlandene) foreslog en alternativ løsning, nemlig i en overgangsperiode at indføre et betalingssystem baseret på Eurostat-justeringskoefficienter og fortsat indsamle oplysninger om udgifterne til vurdering af ansøgninger, som indgives via den centrale procedure.
English: • [EMEA/MB/617640/2009] Summary of transfers of appropriations in the budget 2009.
Danish: • [EMEA/MB/617640/2009] Sammendrag af bevillingsoverførsler på budgettet for 2009.
English: Work programme 2010 [EMEA/MB/203131/2009] The Board adopted the Work programme 2010.
Danish: Arbejdsprogrammet for 2010 [EMEA/MB/203131/2009] Bestyrelsen vedtog arbejdsprogrammet for 2010.
English: The Management Board Telematics Committee prepared and presented to the Board the draft terms of reference.
Danish: Bestyrelsens telematikudvalg havde udarbejdet udkastet til kommissorium og forelagt det for bestyrelsen.
English: The terms of reference will be submitted for adoption at the March 2010 meeting.
Danish: Kommissoriet ville blive forelagt til vedtagelse på mødet i marts 2010.
English: 8 January 2010);
Danish: januar 2010)
English: • [EMEA/MB/528743/2009] Update report on EMEA implementation of the EU telematics strategy.
Danish: • [EMEA/MB/528743/2009] Ajourført rapport om EMEA's gennemførelse af EU's telematikstrategi
English: [EMEA/MB/672992/2009] The agenda was adopted.
Danish: [EMEA/MB/672992/2009] Dagsordenen blev vedtaget.
English: Meeting with the Commissioner designate for health and consumer policy
Danish: Den administrerende direktørs redegørelse for de vigtigste begivenheder Møde med kommissæren med ansvar for sundhed og forbrugerpolitik
English: [EMEA/MB/115339/2004] The Board adopted the revised Management Board rules of procedure, which now include a provision for the setting-up of Management Board committees and groups.
Danish: [EMEA/MB/115339/2004] Bestyrelsen vedtog den reviderede forretningsorden for bestyrelsen, som nu omfattede en bestemmelse om nedsættelse af udvalg og grupper under bestyrelsen.
English: [EMEA/MB/752664/2009] The Board adopted the proposal whereby one patients/consumers' representative will be nominated to the Pharmacovigilance Working Party (PhVWP) as an observer and a second representative will be nominated as an alternate.
Danish: [EMEA/MB/752664/2009] Bestyrelsen vedtog forslaget om, at én patient-/forbrugerrepræsentant ville blive udpeget som observatør i arbejdsgruppen vedrørende lægemiddelovervågning (PhVWP) og en anden repræsentant som suppleant.
English: [EMEA/MB/753771/2009] The Board adopted the proposals aimed at more structured involvement of patients/consumers in the various activities of the Agency.
Danish: [EMEA/MB/753771/2009] Bestyrelsen vedtog forslagene, som tog sigte på en mere struktureret inddragelse af patienter/forbrugere i agenturets forskellige aktiviteter.
English: 5bis.
Danish: 5a.
English: [EMEA/MB/728947/2009] The Board adopted the revised reimbursement rules for delegates.
Danish: [EMEA/MB/728947/2009] Bestyrelsen vedtog de reviderede godtgørelsesregler for delegerede.
English: [EMEA/768926/2009] The Board adopted the 2010 part of the telematics master plan, which forms part of the work programme and budget 2010.
Danish: [EMEA/768926/2009] Bestyrelsen vedtog 2010-delen af telematikmasterplanen, der indgik i arbejdsprogrammet og budgettet for 2010.
English: [EMEA/MB/767563/2009] The Board endorsed the fixed, flat hourly cost for 2010, which is set at the same rate as in 2009.
Danish: [EMEA/MB/767563/2009] Bestyrelsen godkendte den faste, ensartede timesats for 2010, som fastsattes til samme sats som i 2009.
English: [EMEA/MB/737155/2009] The Board adopted the implementing rules, subject to their formal approval by the European Commission.
Danish: [EMEA/MB/737155/2009] Bestyrelsen vedtog gennemførelsesbestemmelserne, med forbehold af Europa-Kommissionens formelle godkendelse heraf.
English: • work on the H1N1 pandemic, including initiatives to address the limited vaccine availability in some
Danish: • arbejdet med H1N1-pandemien, herunder initiativer til at afhjælpe den begrænsede adgang til vaccine i nogle medlemsstater, overvejelser omkring oprettelse af et virtuelt lager og kommunikationsudfordringerne.
English: Minutes from the 64th meeting, held on 1 October 2009 [EMEA/MB/642672/2009] The Management Board noted the adoption of the minutes by written procedure on 13 November 2009.
Danish: møde den 1. oktober 2009 [EMEA/MB/642672/2009] Bestyrelsen noterede sig vedtagelsen af referatet gennem den skriftlige procedure den 13. november 2009.
English: [EMEA/MB/628139/2009; EMEA/MB/700124/2009; EMEA/MB/579221/2008] The Board adopted the budget, the establishment plan and the staff policy plan for 2010, pending the budget decision by the European Parliament.
Danish: [EMEA/MB/628139/2009, EMEA/MB/700124/2009, EMEA/MB/579221/2008] Bestyrelsen vedtog budgettet, stillingsfortegnelsen og planen for personalepolitikken for 2010, i afventning af EuropaParlamentets budgetafgørelse.
English: [EMEA/MB/727972/2009] The Board discussed this agenda point under the work programme and the EU telematics master plan 2010.
Danish: [EMEA/MB/727972/2009] Bestyrelsen drøftede dette dagsordenspunkt i forbindelse med arbejdsprogrammet og EU's masterplan for telematik for 2010.
English: [EMEA/MB/761723/2009; EMEA/MB/736762/2009] The Board noted the status reports on the implementation of EudraVigilance for human and veterinary medicines.
Danish: [EMEA/MB/761723/2009, EMEA/MB/736762/2009] Bestyrelsen noterede sig statusrapporterne om gennemførelsen af EudraVigilance for human- og veterinærmedicinske lægemidler.
English: The representative of the European Commission drew the attention of the Board to the fact that a decision of the Board is necessary notably in the light of the observations of the Court of Auditors (also noting that, for example, in the European Chemicals Agency, the reimbursement rate is based on the cost for the national agency involved (rapporteur) multiplied with a country coefficient).
Danish: Europa-Kommissionens repræsentant gjorde bestyrelsen opmærksom på, at en bestyrelsesbeslutning var nødvendig navnlig i lyset af Revisionsrettens bemærkninger (og bemærkede endvidere, at betalingssatsen i f.eks.
English: • safety-monitoring of medicines;
Danish: • sikkerhedsovervågning af lægemidler
English: [EMEA/MB/752624/2009; EMEA/MB/786453/2009] The Board discussed and adopted the draft road map to 2015 for public consultation.
Danish: [EMEA/MB/752624/2009, EMEA/MB/786453/2009] Bestyrelsen drøftede og vedtog udkastet til køreplan frem til 2015 til offentlig høring.
English: [EMEA/MB/780575/2009; EMEA/MB/762513/2009] The Management Board reviewed the outcomes of the pilot which aimed to assess the costs of assessment of centralised applications by national competent authorities.
Danish: [EMEA/MB/780575/2009, EMEA/MB/762513/2009] Bestyrelsen drøftede resultaterne af pilotprojektet, som tog sigte på at vurdere de nationale kompetente myndigheders evalueringsomkostninger i forbindelse med ansøgninger, som indgives via den centrale procedure.
English: Participants at the 65th meeting of the Management Board
Danish: Deltagerliste for bestyrelsens 65.
English: − Minutes of the 64th meeting of the Management Board.
Danish: Referat af bestyrelsens 64.
English: Minutes of the 65th meeting of the Management Board
Danish: Referat af bestyrelsens 65.
English: United Kingdom Kent Woods European Parliament
Danish: Kent Woods
English: [EMEA/MB/170391/2009/Rev.4] The Board adopted the amendments to the fee implementing rules to come into effect on 1 January 2010.
Danish: 4] Bestyrelsen vedtog de ændringer af gebyrgennemførelsesbestemmelserne, der skulle træde i kraft den 1. januar 2010.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Brimica Genuair on 19 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Brimica Genuair den 19. november 2014.
English: In addition, the safety profile of the two components is well known, and there is no evidence that the combination is worse than the individual components.
Danish: Desuden er sikkerhedsprofilen af de to bestanddele velkendt, og der er ingen tegn på, at kombinationen er ringere end de enkelte bestanddele.
English: The full EPAR and risk management plan summary for Brimica Genuair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Brimica Genuair findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Brimica Genuair.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Brimica Genuair.