FrancophonIA/ELRC3.0 huggingface dataset:
English: Point 6 (budget 2011) was changed from ‘for endorsement' to ‘for adoption'.
Danish: Punkt 6 (budget 2011) blev ændret fra "til godkendelse" til "til vedtagelse".
English: The detected mistakes were not systematic and a control mechanism has been established to reinforce the procedure.
Danish: De påviste fejl var ikke systematiske, og der er blevet etableret en kontrolmekanisme, som skal styrke proceduren.
English: The review of the Fee Regulation is a good opportunity to address the issue.
Danish: Revisionen af gebyrforordningen er en god mulighed for at behandle dette spørgsmål.
English: The European Medicines Agency's comments had been included in the document.
Danish: Det Europæiske Lægemiddelagenturs kommentarer var medtaget i dokumentet.
English: The Agency will also publish comments received during the consultation phase.
Danish: Agenturet offentliggør endvidere kommentarer modtaget under høringsfasen.
English: • Progress in the selection procedure for the Executive Director.
Danish: • Fremskridt i proceduren for udvælgelse af den administrerende direktør.
English: Members were invited to provide their comments and alternative proposals for the 16 March meeting.
Danish: Medlemmerne blev opfordret til at komme med kommentarer og alternative forslag til mødet den 16. marts.
English: This is an overarching document that will be supplemented by specific annexes related to the operational areas in the future.
Danish: Dette er et overordnet dokument, der vil blive suppleret med specifikke bilag vedrørende de operationelle områder i fremtiden.
English: Other priority areas remain similar to the previous years'.
Danish: Andre prioriterede områder svarer til de tidligere års.
English: • Sustainable and responsible competitiveness: the Process on Corporate Responsibility in the field of Pharmaceuticals.
Danish: • Bæredygtig og ansvarlig konkurrenceevne: Processen vedrørende socialt ansvar på lægemiddelområdet.
English: The Board noted that the positive outturn from 2009 was included in the budget.
Danish: Bestyrelsen noterede sig, at det positive resultat fra 2009 var medtaget i budgettet.
English: The Board recognised the significant achievements made during his term of office and thanked him for leading the Agency successfully over the last ten years.
Danish: Bestyrelsen anerkendte de betydelige resultater, der er opnået i løbet af hans mandatperiode, og takkede ham for at have ledet agenturet med succes i de seneste ti år.
English: • Review of the Transparency Directive.
Danish: • Revision af gennemsigtighedsdirektivet.
English: The opinion relates to procurement cases.
Danish: Forbeholdet drejer sig om indkøbssager.
English: This was made possible by reducing the planned expenditure for hardware and software by bringing certain procurements forward.
Danish: Dette blev gjort muligt ved at reducere de planlagte udgifter til hardware og software gennem overførelse af bestemte indkøb.
English: Further information will be provided for the next meeting, when the Management Board will be asked to take a decision.
Danish: Der vil blive givet yderligere oplysninger på næste møde, hvor bestyrelsen vil blive bedt om at træffe en afgørelse.
English: Relationship with the European Centre for Disease Prevention and Control (ECDC)
Danish: Forholdet til Det Europæiske Center for Forebyggelse af og Kontrol med Sygdomme (ECDC)
English: The priorities for 2011 are in line with the 'Road map to 2015' and ensure continuity from the previous years.
Danish: Prioriteterne for 2011 er i overensstemmelse med "Køreplan frem til 2015" og sikrer kontinuitet fra tidligere år.
English: The Agency will be invited to the Council and the Committee on Budgetary Control of the European Parliament to answer questions from the members as part of the discharge process.
Danish: Agenturet vil blive inviteret til Rådet og Europa-Parlamentets Budgetkontroludvalg med henblik på at besvare spørgsmål fra medlemmerne som del af dechargeproceduren.
English: The minutes will be published on the Agency's website.
Danish: Referatet offentliggøres på agenturets websted.
English: Thomas Lönngren ends his 10-year mandate on 31 December 2010.
Danish: Thomas Lönngrens tiårige mandat udløber den 31. december 2010.
English: This was the last Management Board meeting for Thomas Lönngren as the Executive Director of the Agency.
Danish: Dette var det sidste bestyrelsesmøde med Thomas Lönngren som agenturets administrerende direktør.
English: The extraordinary meeting for interviewing and nominating the Executive Director is scheduled for 5 May 2011.
Danish: Det ekstraordinære møde, hvor der vil blive afholdt samtaler og foretaget en udnævnelse af den administrerende direktør, er planlagt til den 5. maj 2011.
English: Preparation for written procedure on non-automatic carryover of appropriations from 2010 to 2011 for Project 2014
Danish: Forberedelse af en skriftlig procedure om ikkeautomatisk overførsel af bevillinger fra 2010 til 2011 for projekt 2014
English: Financial compensation for Member States' participation in linguistic checking - fixed flat hourly cost for 2011
Danish: Økonomisk kompensation for medlemsstaternes deltagelse i den sproglige kontrol - faste timepriser for 2011
English: Initiatives are planned in this field, while ensuring that cost/benefit assessment remains separate from the licensing process.
Danish: Der er planer om initiativer på dette område, samtidig med at det sikres, at cost-benefit-analysen forbliver adskilt fra licensgivningsprocessen.
English: Maarit Kokki of ECDC (point 17)
Danish: Maarit Kokki fra ECDC (punkt 17)
English: Members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Danish: Medlemmerne blev bedt om at afgive erklæring om specifikke interesser, der kunne betragtes som skadelige for deres uafhængighed med hensyn til dagsordenspunkterne.
English: One of the key priorities for the Agency is the implementation of the new pharmacovigilance legislation, including the establishment of the seventh scientific committee.
Danish: En af de vigtigste prioriteter for agenturet er gennemførelsen af den nye lovgivning om lægemiddelovervågning, herunder etableringen af det syvende videnskabelige udvalg.
English: No conflict of interests was declared.
Danish: Der blev ikke afgivet erklæringer om interessekonflikt.
English: The Agency expects to publish the report at the beginning of 2011.
Danish: Agenturet forventer at kunne offentliggøre rapporten i begyndelsen af 2011.
English: Problems may occur particularly where the manufacturer has a quasi-monopoly on the market.
Danish: Der kan navnlig opstå problemer, hvis producenten har en monopollignende stilling på markedet.
English: Work programme 2011
Danish: Arbejdsprogram 2011
English: The access policies will be implemented gradually, taking into account the availability of ICT tools.
Danish: Politikkerne vedrørende aktindsigt gennemføres gradvist under hensyn til ikt-værktøjers tilgængelighed.
English: The Board also noted that the Agency will make an advance payment of the 2010 salary adjustment to all eligible staff by the end of December.
Danish: Bestyrelsen noterede sig endvidere, at agenturet vil foretage en forhåndsbetaling af 2010's lønjustering til alle berettigede ansatte inden udgangen af december.
English: This will be discussed at the Heads of Medicines Agencies meeting and then with stakeholders.
Danish: Dette vil blive diskuteret på mødet for cheferne for de nationale lægemiddelstyrelser og derefter med interessenterne.
English: The Agency is preparing the road map implementation plan, entitled 'From vision to reality'.
Danish: Agenturet forbereder en gennemførelsesplan for køreplanen, der har titlen "Fra vision til virkelighed".
English: However, the Board considers it to be important to understand the actual scope of tasks required by the legislation before a decision is taken about how the two agencies will be involved and leadership decided.
Danish: Bestyrelsen mener dog, at det er vigtigt at forstå opgavernes faktiske omfang i forhold til, hvad der kræves af lovgivningen, inden der træffes en beslutning om, på hvilken måde de to agenturer skal deltage, og hvordan ledelsen skal foregå.
English: The Board was unanimous in its opinion that the procedures should not be suspended in all cases where observations from members are received.
Danish: Bestyrelsen var enstemmig i sin udtalelse om, at procedurerne ikke bør indstilles i alle tilfælde, hvor der modtages observationer fra medlemmer.
English: Transfers of appropriations in the 2010 budget in accordance with Article 23(2) of the Financial Regulation
Danish: Overførsel af bevillinger i 2010-budgettet i overensstemmelse med finansforordningens artikel 23, stk. 2
English: (An impact assessment has been launched, to be followed by a public consultation by March 2011, before issuing a final report by June 2011.)
Danish: (Der er blevet iværksat en konsekvensanalyse, der inden marts 2011 skal følges af en offentlig høring, inden fremlæggelsen af en endelig rapport senest i juni 2011.)
English: Given the complexity of the new tasks and the timelines for implementation, the Agency has prepared a prioritised implementation plan, in collaboration with the European Commission.
Danish: I betragtning af de nye opgavers kompleksitet og tidsplanerne for gennemførelsen har agenturet udarbejdet en prioriteret gennemførelsesplan i samarbejde med Europa-Kommissionen.
English: The Board noted that the Agency is experiencing an increase in the number and complexity of requests for access to documents, which puts pressure on limited resources.
Danish: Bestyrelsen noterede sig, at agenturet oplever en stigning i antallet og kompleksiteten af anmodninger om aktindsigt, hvilket sætter de begrænsede ressourcer under pres.
English: The budget does not cover adequately the costs of ICT projects needed for the implementation of the pharmacovigilance legislation.
Danish: Budgettet dækker ikke i tilstrækkeligt omfang omkostningerne til de ikt-projekter, der er nødvendige for at gennemføre lovgivningen om lægemiddelovervågning.
English: The Board was concerned that resources for the new tasks will not be made available by the European Commission.
Danish: Bestyrelsen var bekymret for, at Europa-Kommissionen ikke vil stille ressourcer til rådighed til de nye opgaver.
English: The reduction is largely due to a lower than requested Community contribution (-€8.64 million) and reduced fee revenue estimates (-€1.96 million).
Danish: Reduktionen skyldes hovedsaglig et fællesskabsbidrag, der er lavere end ønsket (-8,64 mio. euro), og et reduceret overslag over gebyrindtægter (-1,96 mio. euro).
English: The arrangements had been endorsed by the Management Board of ECDC, and will enter into force once signed by the Directors of both agencies.
Danish: Aftalerne skal godkendes af ECDC's bestyrelse og træder i kraft, når de er blevet underskrevet af direktørerne for begge agenturer.
English: Fred Hargreaves of BNP Paribas Real Estate (point 16)
Danish: Fred Hargreaves fra BNP Paribas Real Estate (punkt 16)
English: The road map underwent extensive public consultation, during which 71 contributions were received from EU Institutions, Member State competent authorities, European patients/consumers' organisations, European healthcare professionals' organisations and other stakeholders.
Danish: Køreplanen var genstand for en omfattende offentlig høring, hvor der blev modtaget 71 bidrag fra EU's institutioner, kompetente myndigheder i medlemsstaterne, europæiske patient/forbrugerorganisationer, europæiske lægeorganisationer og andre interessenter.
English: The European Commission representatives stressed the need for proper planning of ICT, clarified that the development of the EudraVigilance database should remain a priority, and informed that work is in progress on a review of the Fees Regulation.
Danish: Europa-Kommissionen understregede behovet for korrekt planlægning af ikt, præciserede, at udviklingen af EudraVigilance-databasen fortsat bør være en prioritet, og oplyste, at der arbejdes på en revision af gebyrforordningen.
English: Coupled with this is the need to continue addressing areas where there is duplication of work within the network.
Danish: Kombineret hermed er der behov for fortsat at behandle områder med dobbeltarbejde inden for netværket.
English: A new Pharmacovigilance Risk Assessment Committee will be established.
Danish: Der vil blive nedsat et nyt udvalg for risikovurdering inden for lægemiddelovervågning.
English: Since these appropriations cannot be subject to nonautomatic carry-over, it is essential for the Agency to make the payment using the earmarked appropriations from the 2010 budget to avoid a major strain on the 2011 budget next year.
Danish: Eftersom disse bevillinger ikke kan gøres til genstand for en ikke-automatisk overførsel er det afgørende for agenturet, at betalingen foretages ved hjælp af de øremærkede bevillinger fra 2010-budgettet for at undgå en større belastning af 2011-budgettet næste år.
English: • Development of the new strategy to control antimicrobial resistance (announcement by the Commission in November 2010 of its intention to develop a five-year strategy).
Danish: • Udvikling af den nye strategi til kontrol af antimikrobiel resistens (Kommissionen meddelte i november 2010, at den havde til hensigt at udvikle en femårig strategi).
English: Those competencies should be clearly reflected in the CVs of nominees, and an explanation given in cases where the relevance of the expertise of proposed candidates is not obvious.
Danish: Disse kompetencer bør fremgå tydeligt af kandidaternes CV'er, og der bør gives en forklaring i de tilfælde, hvor relevansen af de foreslåede kandidaters ekspertise ikke er oplagt.
English: This is a common challenge for the network, and ways to manage workload in this area need to be found.
Danish: Dette er en almindelig udfordring for netværket, og der er behov for at finde måder at håndtere arbejdsmængden på dette område på.
English: Members also reflected on what could be a desirable professional profile (scientific, regulatory, other) of members of the scientific committees, and how this can be demonstrated.
Danish: Medlemmerne overvejede endvidere, hvad der kunne være en ønskelig professionel profil (med hensyn til videnskabelige, reguleringsmæssige og andre kompetencer) for medlemmer af de videnskabelige udvalg, og hvordan denne kan påvises.
English: The budget is in line with the work programme and totals €208.9 million (0.23% increase over the 2010 budget), which includes a general EU contribution of €28 million, the 2009 surplus of €5.4 million and the €4.9 million orphan medicinal products fund.
Danish: Budgettet er i overensstemmelse med arbejdsprogrammet og udgør i alt 208,9 mio. euro (en stigning på 0,23 % i forhold til 2010-budgettet), hvilket omfatter et generelt EU-bidrag på 28 mio. euro, overskuddet fra 2009 på 5,4 mio. euro og 4,9 mio. euro til finansiering af lægemidler til sjældne sygdomme.
English: Declarations of conflict of interests
Danish: Erklæringer om interessekonflikt
English: As a consequence, the Agency will not be able to draw on reserve funds in case of decrease of forecast fee revenue or to use these funds to finance EU telematics.
Danish: Som en konsekvens heraf vil agenturet ikke kunne trække på reservemidler, hvis den forventede gebyrindtægt falder, eller bruge disse midler til finansiering af EU-telematikken.
English: However, the German member highlighted that, although the majority of products are used locally, the German national competent authority detects most problems in the area of quality defects, rather than in the area of contamination by infectious agents.
Danish: Det tyske medlem fremhævede dog, at selvom størstedelen af lægemidlerne anvendes lokalt, opdager den tyske kompetente myndighed flest problemer med relation til kvalitetsfejl, snarere end til forurening med smitsomme stoffer.
English: During the discussion, it was noted that the vast majority of SoHO are used in the area of transplantation and only a small number of them are used for the manufacturing of advanced therapy medicinal products (ATMPs).
Danish: Under drøftelsen blev det bemærket, at størsteparten af stofferne af menneskelig oprindelse anvendes i forbindelse med transplantationer, og at det kun er en mindre del, der anvendes til fremstilling af lægemidler til avanceret terapi (ATMP'er).
English: ICT planning and priorities 2011
Danish: Itk-planlægning og -prioriteter 2011
English: In addition, the Agency sets out its long-term objectives in the following three domains: addressing public-health needs, facilitating access to medicines, and optimising the safe and rational use of medicines.
Danish: Derudover fastlægger agenturet sine langsigtede mål på følgende tre områder: opfyldelse af behov for offentlig sundhedspleje, fremme af adgang til lægemidler og optimering af en sikker og rationel brug af lægemidler.
English: As discussed at earlier meetings, one of the options is to amend the format of application dossiers in such a way that publication of non-confidential information can be done without redaction.
Danish: Som drøftet på tidligere møder er en af mulighederne at ændre formatet på ansøgningsdossiererne således, at ikke-fortrolige oplysninger kan offentliggøres uden redigering.
English: Once implemented, the policies will provide stakeholders with different levels of access to suspected adverse reaction reports contained in the EudraVigilance database.
Danish: Når disse politikker er gennemført, vil de give interessenterne forskellige adgangsniveauer til indberetninger om formodede bivirkninger, der er indeholdt i EudraVigilance-databasen.
English: In its work programme, the Agency also addresses the expectations of closer collaboration between the regulators and health technology assessment bodies.
Danish: Agenturet behandler i sit arbejdsprogram endvidere forventningerne om et tættere samarbejde mellem reguleringsmyndighederne og de medicinske teknologivurderingsorganer.
English: • Legislative proposal on falsified medicines (agreement is expected in the first reading; publication is expected by March and entry into force 18 months later).
Danish: • Lovforslag vedrørende forfalskede lægemidler (der forventes en aftale i førstebehandlingen, offentliggørelse inden marts og ikrafttrædelse 18 måneder senere).
English: • Legislative proposals on information to patients (the European Parliament adopted its resolution in November 2010, and on this basis the Commission will present a modified proposal).
Danish: • Lovforslag vedrørende information til patienter (Europa-Parlamentet vedtog sin beslutning i november 2010, og Kommissionen fremlægger et ændret forslag på baggrund heraf).
English: Road map to 2015
Danish: Køreplan frem til 2015
English: The members stressed that remuneration of national competent authorities for non-fee related activities is particularly acute, and needs to be addressed to assure sustainable performance of the network.
Danish: Medlemmerne understregede, at spørgsmålet om godtgørelse til de kompetente nationale myndigheder for aktiviteter, der ikke er gebyrrelaterede, er særligt presserende og skal behandles for at sikre bæredygtige resultater af netværket.
English: Specifically, the meeting focused on issues such as handling of observations and comments received from members during the consultation procedures, whether or not it is practical to suspended certain procedures and defer them for discussion to the Management Board plenary meetings, and whether chairs of committees need to be consulted.
Danish: Specifikt fokuserede mødet på emner såsom behandlingen af observationer og kommentarer, der modtages fra medlemmer under høringsprocedurerne, spørgsmålet om, hvorvidt det er praktisk at indstille bestemte procedurer og overdrage dem til drøftelse på bestyrelsens plenarmøder, og om der er behov for at høre formændene for udvalgene.
English: With the adoption of the new road map, the Agency increasingly emphasises the importance of a balanced view of benefits and risks of medicines.
Danish: Med vedtagelsen af køreplanen understreger agenturet i højere grad vigtigheden af et afbalanceret syn på lægemidlers fordele og risici.
English: The Board endorsed the document that was prepared following a teleconference with the Management Board topic coordinators (the Chair, Austria, Denmark and France).
Danish: Bestyrelsen godkendte dokumentet, der er udarbejdet på baggrund af en telekonference med bestyrelsens emnekoordinatorer (formanden, Østrig, Danmark og Frankrig).
English: Following the conference at which the outcomes of the evaluation of the Agency were discussed, a report has been prepared and submitted to the European Commission.
Danish: Efter konferencen, hvor resultaterne af agenturets evaluering blev drøftet, er der blevet udarbejdet en rapport, der er blevet sendt til Europa-Kommissionen.
English: A lessons-learned exercise, based on the experience of the ongoing quality defect situation, will be completed, and the Agency will explore this issue with the European Commission.
Danish: Der vil blive gennemført en erfaringsbaseret øvelse på baggrund af erfaringerne med den nuværende situation med kvalitetsmangler, og agenturet vil undersøge dette emne sammen med Europa-Kommissionen.
English: Draft agenda for 16 December 2010 meeting
Danish: Forslag til dagsorden for mødet den 16. december 2010
English: The adoption follows the public consultation, and takes into account comments received from the European Data Protection Supervisor (EDPS) and the European Ombudsman (EO) and provisions of the recently adopted pharmacovigilance legislation, which requires the Agency to improve access for stakeholders.
Danish: Vedtagelsen sker efter den offentlige høring og tager højde for de kommentarer, der er modtaget fra Den Europæiske Tilsynsførende for Databeskyttelse og Den Europæiske Ombudsmand samt bestemmelser i den nyligt vedtagne lovgivning om lægemiddelovervågning, som kræver, at agenturet forbedrer adgangen for interessenter.
English: Together with the Member States, the Agency has set up project teams, which are working under the leadership and supervision of the project oversight committee and the coordination group.
Danish: Agenturet har sammen med medlemsstaterne nedsat projektgrupper, som arbejder under projekttilsynsudvalget og koordineringsgruppens ledelse og tilsyn.
English: Members were of the opinion that committees should consist of a mixture of expertise (scientific and expertise in evaluating benefit/risk balance).
Danish: Medlemmerne var af den opfattelse, at udvalg bør består af en blanding af forskellige ekspertiser (videnskabelig ekspertise og ekspertise i forbindelse med evaluering af risk/benefit-forhold).
English: The members noted the update report from the European Commission on a range of topics, including the following:
Danish: Medlemmerne tog Europa-Kommissionens opdaterede rapport om flere emner til efterretning.
English: The Board also highlighted that the Board should consider the individual circumstances of national competent authorities, and the fact that committee members are supported by multidisciplinary expertise in the national competent authorities.
Danish: Bestyrelsen fremhævede endvidere, at bestyrelsen bør tage højde for de nationale kompetente myndigheders individuelle forhold og det faktum, at udvalgsmedlemmer får støtte i form af tværfaglig ekspertise fra de nationale kompetente myndigheder.
English: The Board thanked the topic coordinators (the Chair, Austria and the Netherlands) who reviewed the Agency's work programme and budget ahead of the meeting and provided their recommendations.
Danish: Bestyrelsen takkede emnekoordinatorerne (formanden, Østrig og Nederlandene), som gennemgik agenturets arbejdsprogram og budget forud for mødet og fremsatte deres anbefalinger.
English: Points 8 (Implementation of budget 2011 with provisional twelfth) and 10 (transfers of appropriations in accordance with Article 23 (2) of the Financial Regulation) were cancelled.
Danish: Punkt 8 (gennemførelse af budget 2011 med formålsbestemt reserve 12) og 10 (bevillingsoverførsler i overensstemmelse med finansforordningens artikel 23, stk. 2) blev slettet.
English: List of participants
Danish: Liste over deltagere