FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the discussion of the Management Board at the December meeting about the gap between workload and the number of temporary agents, the Agency requested 34 posts to replace existing contract agent positions with temporary agent positions.
Danish: Efter bestyrelsens drøftelser på mødet i december om kløften mellem arbejdsbyrden og antallet af midlertidigt ansatte anmodede agenturet om oprettelse af 34 stillinger som midlertidigt ansatte, der skulle erstatte de eksisterende stillinger som fastansatte.
English: Timely engagement between regulators and industry is needed to assure that more products pass the regulatory assessment.
Danish: Der var brug for rettidige forpligtelser mellem de lovgivende myndigheder og industrien for at sikre, at flere lægemidler består den forskriftsmæssige vurdering.
English: The Board also stressed that the Agency's guidance relating to new and emerging therapies is highly important in the light of scientific development.
Danish: Bestyrelsen understregede også, at agenturets vejledning vedrørende nye og avancerede terapier var yderst vigtig i lyset af den videnskabelige udvikling.
English: • Progress on the pharmaceutical package (legislative proposals on pharmacovigilance, falsified medicines and the proposal on provision of information to patients).
Danish: • Fremskridt med lægemiddelpakken (lovgivningsforslag om lægemiddelovervågning og kopimedicin og forslaget om formidling af information til patienter).
English: Draft agenda for 18 March 2010 meeting
Danish: Forslag til dagsorden for mødet den 18. marts 2010
English: The priorities for 2011 are consistent with previous years and the Road Map to 2010.
Danish: Prioriteringerne for 2011 var de samme som de foregående år og i overensstemmelse med køreplanen frem til 2010.
English: Revised Management Board consultation procedure for CHMP and CVMP nominations
Danish: Revision af bestyrelsens konsultationsprocedure om udnævnelser til CHMP og CVMP
English: The Board noted that a number of non-EU countries used EU authorisation to grant authorisation of pandemic vaccines in their own countries.
Danish: Bestyrelsen bemærkede, at en række tredjelande anvendte EU-godkendelse til at godkende pandemiske vacciner i deres egne lande.
English: The Board also stressed that Member States continued to have reservations as to the ability to record time on an ongoing basis.
Danish: Bestyrelsen understregede også, at medlemsstaterne fortsat havde forbehold med hensyn til at kunne registrere tid løbende.
English: The report shows that the Agency's performance with regard to the growing core business remained at a high standard, despite the fact that significant resources were dedicated to pandemic work throughout the year.
Danish: Beretningen viste, at agenturet fortsat opnåede gode resultater, hvad angik dets voksende kernevirksomhed, på trods af at der blev brugt væsentlige ressourcer på arbejdet med pandemien gennem hele året.
English: The impact of the recent legislation on variations should be seen in 2010 and will need to be taken into account in 2011.
Danish: Den seneste lovgivnings virkning på afvigelserne ville kunne ses i 2010, og der skulle tages højde herfor i 2011.
English: The first meeting of chairs of the management boards of EU agencies took place to share best practices and discuss common issues and challenges.
Danish: Det første møde mellem EU-agenturernes bestyrelsesformænd fandt sted med henblik på at udveksle bedste praksis og drøfte spørgsmål og udfordringer af fælles interesse.
English: • improving the output of the Committee;
Danish: • forbedring af udvalgets resultater
English: Mr Dalli had extensive meetings with key staff of the Agency, and also outlined his priorities and replied to the questions of staff members.
Danish: John Dalli holdt lange møder med nøglemedarbejdere fra agenturet, skitserede sine prioriteringer og svarede på spørgsmål fra medarbejderne.
English: The Executive Director will write to members of the Board before June concerning the appointment of a Chair.
Danish: Den administrerende direktør ville skrive til bestyrelsesmedlemmerne inden juni vedrørende udnævnelsen af en formand.
English: The PDB includes an increase of 48 posts in the establishment plan, to a maximum number of 615 temporary agents.
Danish: Det foreløbige budgetforslag omfattede en stigning i antallet af stillinger på 48 til et maksimalt antal midlertidigt ansatte på 615.
English: Annual report 2009
Danish: Årsberetningen for 2009
English: • the work of the HMA task force on improvement of veterinary legislation;
Danish: • HMA-taskforcens arbejde på at forbedre veterinærlovgivningen
English: The adopted preliminary work programme will be further modified in the course of 2010 to take into account the outcome of the evaluation of the Agency and its Road Map to 2015.
Danish: Det vedtagne foreløbige arbejdsprogram ville blive redigeret yderligere i løbet af 2010 for at tage højde for resultatet af evalueringen af agenturet og dets køreplan frem til 2015.
English: A number of issues were raised, relating to the availability of genotoxicity data by Member States, distribution of rapporteurships among Member States, and the impact of the strict requirements of the conflicts-of-interest policy on the availability of scientific expertise.
Danish: Der blev rejst en række spørgsmål vedrørende tilgængeligheden af genotoksiske data fra medlemsstaterne, fordelingen af ordførerskaber blandt medlemsstaterne og effekten af de strenge krav i politikken vedrørende interessekonflikter i forbindelse med tilgængeligheden af videnskabelige fagfolk.
English: The action plan will now be discussed at the Heads of Medicines Agencies in April.
Danish: Handlingsplanen ville blive drøftet af cheferne for de nationale lægemiddelstyrelser i april.
English: The Agency will also start preparing for the implementation of legislation on pharmacovigilance and falsified medicines.
Danish: Agenturet ville også begynde at forberede sig på gennemførelsen af lovgivning om lægemiddelovervågning og kopimedicin.
English: The Commission will write to the Chair to confirm specific dates for the shortlist of candidates to enable the Board to plan for an extraordinary meeting.
Danish: Kommissionen ville skrive til formanden for at bekræfte specifikke datoer vedrørende den begrænsede liste over ansøgere, så bestyrelsen kunne planlægge et ekstraordinært møde.
English: Board members raised concerns about the process by which DG Sanco has apparently decided to give the mandate for vigilance of cells and tissues to ECDC.
Danish: Bestyrelsens medlemmer udtrykte bekymring over, at GD Sanco åbenbart havde besluttet sig for at give mandatet vedrørende overvågning af celler og væv til Det Europæiske Center for Forebyggelse af og Kontrol med Sygdomme (ECDC).
English: The PDB for 2011 totals €218.9 million, in line with the work programme.
Danish: Det foreløbige budgetforslag for 2011 udgjorde 218,9 mio. EUR, hvilket var i overensstemmelse med arbejdsprogrammet.
English: With regard to EPARs, the Board suggested that work should continue to promote them in the medical and scientific community, as these documents contain very valuable information about the evaluation of medicines and the decision-making process.
Danish: Hvad angik EPAR'er, foreslog bestyrelsen, at disse fortsat skulle fremmes i det medicinske og videnskabelige samfund, da disse dokumenter indeholdt meget værdifulde oplysninger om evalueringen af lægemidler og beslutningsprocesserne.
English: The adequacy of available genotoxicity data should be judged on a case-by-case basis and the request for new data should be made when there is a specific concern for safety.
Danish: Relevansen af tilgængelige genotoksiske data skulle bedømmes i hvert enkelt tilfælde, og der skulle rejses anmodning om nye data, når der forelå specifikke betænkeligheder med hensyn til sikkerheden.
English: As a consequence, the number of contract agents will decrease by 35 in 2011 compared to 2010.
Danish: Følgelig faldt antallet af fastansatte med 35 i 2011 i forhold til 2010.
English: Nuno Simoes Hélder Mota Philipe
Danish: Nuno Simões Hélder Mota Philipe
English: The conference will address the topics raised in the evaluation and will also be an opportunity to discuss key issues proposed in the Agency's draft road map to 2015.
Danish: På konferencen ville de emner, som var fremsat i evalueringen, blive behandlet, og der ville også være mulighed for at drøfte centrale punkter i agenturets udkast til køreplan frem til 2015.
English: The Board expressed its support for the vaccination strategies adapted by Member States in the wake of a potentially severe pandemic threat.
Danish: Bestyrelsen gav udtryk for, at den støttede medlemsstaternes vaccinationsstrategier i kølvandet på den potentielt alvorlige pandemiske trussel.
English: This is particularly true for areas where targets are self-set, as for example in the area of European public assessment reports (EPARs), where a number of self-set targets are not achieved due to circumstances outside of the Agency's reach.
Danish: Dette gjalt særlig områder, hvor agenturet selv havde fastlagt målsætninger, som f.eks. i forbindelse med europæiske offentlige vurderingsrapporter (EPAR'er), hvor en række målsætninger, som det selv havde fastlagt, ikke kunne realiseres på grund af omstændigheder, som agenturet ikke havde indflydelse på.
English: The Board also noted that issues exist in the area of the registration of traditional herbal medicinal products which can lead to products being marketed under another classification, e.g. food supplements.
Danish: Bestyrelsen bemærkede desuden, at der var problemer i forbindelse med registreringen af traditionelle plantelægemidler, hvilket kunne medføre, at produkter blev markedsført under en anden klassificering, f.eks. kosttilskud.
English: The Management Board welcomed the presentation of the Chair of the Committee on Herbal Medicinal Products.
Danish: Bestyrelsen hilste præsentationen fra formanden for Udvalget for Plantelægemidler velkommen.
English: The Board also requested that the Agency send for information copies of scientific articles that are written by the Agency's staff.
Danish: Bestyrelsen anmodede også agenturet om at anmode om kopier af videnskabelige artikler, som agenturets personale havde skrevet.
English: The MBTC and Heads of Medicines Agencies telematics group will work to ensure optimum collaboration.
Danish: MBTC og HMAtelematikgruppen ville bestræbe sig på at sikre et optimalt samarbejde.
English: [EMA/MB/183091/2010] The Management Board adopted the amendments to the reimbursement rules for delegates, whereby an allowance, corresponding to 35% of the maximum cost of a hotel night (€60 for London), is introduced to provide financial support to delegates where no accommodation invoices can be provided.
Danish: [EMA/MB/183091/2010] Bestyrelsen vedtog ændringerne af refusionsreglerne for delegerede, og der indførtes således en godtgørelse svarende til 35 % af de maksimale udgifter til en hotelnat (60 EUR for London) for at yde økonomisk støtte til delegerede, når der ikke kunne fremvises fakturaer for indkvartering.
English: The draft budget also includes resource needs for the implementation of the future pharmacovigilance and counterfeit medicines legislation, which were challenged by the Commission as being higher than estimated.
Danish: Budgetforslaget omfattede også ressourcebehov til gennemførelse af den kommende lovgivning om lægemiddelovervågning og kopimedicin, som ifølge Kommissionen var højere end anslået.
English: The revised implementing rules will enter into force on 1 April 2010.
Danish: De reviderede gennemførelsesbestemmelser ville træde i kraft den 1. april 2010.
English: The Board also commented that the quality of dossiers may be a significant factor, and it is likely that a number of the products that received a negative opinion could have been approved if the dossiers had been of a higher standard.
Danish: Bestyrelsen bemærkede desuden, at dossierkvaliteten kunne være en afgørende faktor, og en række af de lægemidler, der blev afvist, kunne sandsynligvis være blevet godkendt, hvis dossiererne havde været af en højere standard.
English: The Agency will now work to identify lessons learned from the pandemic situation to identify improvements for future situations of this nature.
Danish: Agenturet ville nu forsøge at drage lære af erfaringerne fra pandemien i lignende situationer i fremtiden.
English: The Board discussed the need to enhance the number of list entries, but noted the hurdles posed by the unavailability of genotoxicity data.
Danish: Bestyrelsen drøftede behovet for at udvide antallet af optagelser på listen, men bemærkede de forhindringer, som den manglende tilgængelighed af genotoksiske data udgjorde.
English: Members stressed that a very short lead time from identification of the threat to the start of vaccination was only possible due to cooperation of regulators and industry.
Danish: Medlemmerne understregede, at det kun kunne lade sig gøre at påbegynde vaccinationerne så kort tid efter, at truslen var blevet identificeret, på grund af samarbejdet mellem myndighederne og industrien.
English: The revised rules will enter into force on 1 April 2010.
Danish: De reviderede regler ville træde i kraft den 1. april 2010.
English: The Committee discussed the overall governance arrangements of the telematics programme.
Danish: Udvalget drøftede de overordnede ledelsesmæssige tiltag i forbindelse med telematikprogrammet.
English: Concern was expressed that the decision was taken prematurely, without due examination of the issue and discussion with all stakeholders.
Danish: tidligt uden en passende undersøgelse af emnet og drøftelser med alle interessenterne.
English: Management Board Telematics Committee (MBTC)
Danish: Telematikudvalget under bestyrelsen (MBTC)
English: Evaluation of the Agency by the European Commission
Danish: Europa-Kommissionens evaluering af agenturet
English: The amendments concern the adjustment of fees to inflation (increase by 1%), establishing reduced fees for applications for marketing authorisation for multi-strain dossiers, adapting the fees for extensions of marketing authorisations and clarifying reporting requirements for national competent authorities.
Danish: Ændringerne vedrørte en justering af gebyrerne i forhold til inflationen (en stigning på 1 %), en nedsættelse af gebyrerne for ansøgninger om markedsføringstilladelse i forbindelse med multi-strain-materialer, en tilpasning af gebyrerne for udvidelser af markedsføringstilladelser og en præcisering af rapporteringskravene til de nationale kompetente myndigheder.
English: The Chair also informed the Board that the Chair of the Audit Advisory Committee is preparing a reflection paper for the Board, which will set out options for the future of the Committee.
Danish: Formanden oplyste også bestyrelsen om, at formanden for Det Rådgivende Revisionsudvalg var i gang med at udarbejde et arbejdsdokument, som indeholdt oplysninger om udvalgets fremtidsmuligheder.
English: The amendments may concern the reduction of fee income due to revised inflation rate, possible use of part of the surplus from 2008, increase in orphan medicinal products budget, financing ICT expenditure, and consultancy services aimed to identify options for future accommodation for the Agency.
Danish: Ændringerne kunne vedrøre en reduktion af gebyrindtægterne på grund af den reviderede inflationssats, en eventuel anvendelse af en del af overskuddet fra 2008, en stigning i budgettet til lægemidler til sjældne sygdomme, finansiering af IKT-udgifter og konsulentbistand med henblik på at finde nye lokaler til agenturet.
English: The Management Board supported the conversion of these contract agent posts to temporary agent posts as essential in the Agency's efforts to recruit and retain scientific and highly specialised expertise.
Danish: Bestyrelsen udtrykte sin støtte til omdannelsen af disse stillinger som fastansatte til stillinger som midlertidigt ansatte, da det var væsentligt i forbindelse med agenturets bestræbelser på at rekruttere og fastholde videnskabelige og højt specialiserede fagfolk.
English: Draft work programme and budget 2011
Danish: Udkast til arbejdsprogram og budget for 2011
English: [EMA/MB/6505/2010; EMA/MB/68936/201; EMA/MB/125880/2010] The Management Board adopted the preliminary work programme, preliminary draft budget (PDB) and draft staff policy plan for 2011.
Danish: [EMA/MB/6505/2010; EMA/MB/68936/201; EMA/MB/125880/2010] Bestyrelsen vedtog det foreløbige arbejdsprogram, det foreløbige budgetforslag (FBF) og udkastet til personalepolitisk plan for 2011.
English: Report from the European Commission
Danish: Rapport fra Kommissionen
English: • [EMA/61092/2010] Update report on the Agency's implementation of the EU telematics strategy.
Danish: • [EMA/61092/2010] Ajourført rapport om agenturets gennemførelse af EU's telematikstrategi
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:
Danish: Rapport fra cheferne for de nationale lægemiddelstyrelser Medlemmerne noterede sig den ajourførte rapport fra cheferne for de nationale lægemiddelstyrelser om en lang række emner, herunder:
English: [EMA/MB/3790/2010] The agenda was adopted.
Danish: [EMEA/MB/3790/2010] Dagsordenen blev vedtaget.
English: Action plan for herbal medicines for 2010-2011
Danish: Handlingsplan for plantelægemidler for 2010-2011
English: − [EMA/78873/2010] Survey 2009 for medicinal products for human use;
Danish: [EMA/78873/2010] Undersøgelse for 2009 om humanlægemidler
English: Held in London on 17-18 March 2010
Danish: møde i London den 17-18. marts 2010
English: [EMA/MB/281553/2007Rev.2] The Management Board adopted the revised procedure.
Danish: [EMA/MB/281553/2007Rev.2] Bestyrelsen vedtog den reviderede procedure.
English: The Committee watched presentations by the chairs of the telematics implementation groups.
Danish: Udvalget overværede præsentationer fremlagt af formændene for grupperne til implementering af telematik.
English: Giuseppe Nisticó
Danish: Giuseppe Nisticò
English: • [EMA/MB/121058/2010] Minutes from the first MBTC meeting, held on 9 December 2009, adopted on 9 February 2010.
Danish: • [EMA/MB/121058/2010] Referat fra det første MBTC-møde den 9. december 2009, vedtaget den 9.
English: 26 April 2010 EMA/MB/194352/2010
Danish: 26. april 2010 EMA/440619/2011
English: Data indicate that small companies suffer higher rates of negative outcomes.
Danish: Data viste, at det især var små virksomheder, der modtog negative svar.
English: The following colleagues put their names forward to assist in this task: Chair, Austria, Estonia, Ireland,
Danish: Følgende kolleger meldte sig til at hjælpe med denne opgave: Formanden, Østrig, Estland, Irland, Tyskland, Spanien, Nederlandene og Mike O'Donovan.
English: Revised delegate reimbursement rules
Danish: Reviderede refusionsregler for delegerede
English: Preliminary draft budget 2011 (PDB)
Danish: Foreløbigt budgetforslag for 2011 (FBF)
English: [EMA/MB/75924/2010] A written procedure will be launched in April or May to amend the budget 2010.
Danish: [EMA/MB/75924/2010] Der ville i april eller maj blive indledt en skriftlig procedure om ændring af budgettet for 2010.
English: • Extending & improving judgement presentation.
Danish: • Præsentation om forbedring af bedømmelsesevnen.
English: [EMA/MB/142837/2010] The Management Board endorsed an action plan for herbal medicinal products.
Danish: [EMA/MB/142837/2010] Bestyrelsen godkendte en handlingsplan for plantelægemidler.
English: • [EMEA/MB/617640/2009] Summary of transfers of appropriations in the budget 2009.
Danish: • [EMEA/MB/617640/2008] Sammendrag af bevillingsoverførsler på budgettet for 2009
English: List of participants at the 66
Danish: Liste over deltagere ved bestyrelsens 66.
English: Meeting of the chairs of the management boards of EU agencies
Danish: Møde mellem EU-agenturernes bestyrelsesformænd
English: [EMA/MB/69923/2010] The Management Board adopted the Agency's annual report 2009.
Danish: [EMA/MB/69923/2010] Bestyrelsen vedtog agenturets årsberetning for 2009.
English: − [EMA/MB/117221/2010] Note on veterinary products.
Danish: [EMA/MB/117221/2010] Note om veterinærmedicinske lægemidler
English: • Capabilities & limitations of human judgement presentation.
Danish: • Præsentation om menneskelige evner og begrænsninger i forbindelse med beslutningstagning
English: • Action plan for herbal medicines 2010-2011 presentation.
Danish: • Præsentation af handlingsplan for plantelægemidler for 2010-2011
English: • [EMA/MB/84539/2010] Outcome of written procedures during the period from 21 November 2009
Danish: • [EMA/MB/84539/2010] Resultat af skriftlige procedurer i perioden fra den 21. november 2009 til den 25. februar 2010
English: b) Terms of reference
Danish: b) Vilkår
English: • Agenda point 8bis_Amendment of the reimbursement rules for delegates.
Danish: 8a: Reviderede refusionsregler for delegerede
English: [EMA/MB/64422/2010] The Management Board adopted the terms of reference of the Management Board Telematics Committee.
Danish: [EMA/MB/64422/2010] Bestyrelsen vedtog vilkårene for telematikudvalget under bestyrelsen.
English: Specifically, the sessions presented how to extend human capabilities in decision making and also demonstrated case studies where models were applied to extend and improve human judgement.
Danish: Der blev fremlagt casestudier, hvor der var blevet anvendt modeller til forbedring af menneskers dømmekraft.
English: Minutes of the 66th meeting of the Management Board
Danish: Referat af bestyrelsens 66.
English: • [EMEA/MB/115245/2010] Annual report 2009 of the Agency's Audit Advisory Committee.
Danish: • [EMEA/MB/115245/2010] Årsberetning for 2009 fra agenturets rådgivende revisionsudvalg
English: [EMA/MB/806136/2009] The Management Board adopted the minutes with the following changes under point 12 (payment system to Member States): The Board clarified that only those countries which participated in the pilot demonstrated ability to identify hourly rates for services provided and to record time spent on centralised applications.
Danish: 12 (betalingssystem til medlemsstaterne): Bestyrelsen præciserede, at det kun var de lande, der deltog i pilotprojektet, som godtgjorde, at de var i stand til at identificere timepriser for leverede tjenesteydelser og registrere den tid, der blev brugt på centraliserede ansøgninger.
English: • [EMEA/MB/115301/2010] Annual report 2009 of the Agency's Internal Audit.
Danish: • [EMEA/MB/115301/2010] Årsberetning for 2009 fra agenturets interne revisionstjeneste
English: Term of office of the Chair of the Board
Danish: Bestyrelsesformandens mandatperiode
English: Preliminary work programme 2011
Danish: Udkast til arbejdsprogram for 2011
English: Gro Ramsten Wesenberg (Norway) Brigitte Batliner (Liechtenstein)
Danish: Brigitte Batliner (Liechtenstein)
English: Rannveig Gunnarsdóttir (Iceland)
Danish: Rannveig Gunnarsdóttir (Island) Gro Ramsten Wesenberg (Norge)
English: Sanco.
Danish: til GD Sanco.
English: • HMPC presentation.
Danish: • Præsentation af Udvalget for Plantelægemidler (HMPC)
English: Minutes from the 65th meeting, held on 10 December 2009
Danish: møde den 10. december 2009
English: [EMA/MB/818152/2009] The Management Board adopted the amendments to the Fee Regulation implementing rules.
Danish: [EMA/MB/806136/2009] Bestyrelsen godkendte referatet med følgende ændringer under pkt.
English: Date of first authorisation: 14 September 1998 Date of latest renewal: 14 September 2008
Danish: Dato for første markedsføringstilladelse: 14. september 1998 Dato for seneste fornyelse: 14. september 2008
English: Dissolve in the mouth.
Danish: Opløses i munden.
English: See section 4.
Danish: Se punkr 4.
English: If you have a deformity of your penis or Peyronie's Disease.
Danish: hvis du har en deformitet af penis eller Peyronies sygdom.
English: This medicinal product does not require any special temperature storage conditions.
Danish: Dette lægemiddel kræver ingen særlige opbevaringsbetingelser.
English: If you have problems with your heart.
Danish: hvis du har problemer med hjertet.