FrancophonIA/ELRC3.0 huggingface dataset:
English: • The progress on the "pharmaceutical package"; pharmacovigilance legislation which is due to become applicable in mid-2012), legislative proposals on preventing entry into legal supply chain of falsified medicines and information to patients).
Danish: • Fremskridt med lægemiddelpakken - lægemiddelovervågningslovgivning, som vil finde anvendelse fra midten af 2012 (lovgivningsforslag om forhindring af, at lægemidler, som er forfalskede,
English: The meeting considered that a special session is needed at the Management Board to gain a more thorough overview of work done in the area of health technology assessment at the level of the Council and the European Parliament.
Danish: På mødet mente man, at der var behov for et ekstraordinært bestyrelsesmøde for at få et mere indgående overblik over det arbejde, der gøres inden for området sundhedsteknologivurdering i Rådet og Europa-Parlamentet.
English: Members discussed whether the new policy may restrict participation of representatives of patients and academia in EMA activities, particularly in cases of smaller organisations.
Danish: Medlemmerne drøftede, hvorvidt den nye strategi eventuelt ville begrænse deltagelsen af repræsentanter for patienter og den akademiske verden i EMA's aktiviteter, navnlig i forbindelse med mindre organisationer.
English: Financing of the Agency
Danish: Finansiering af agenturet
English: Lisette Tiddens-Engwirda and Jean Marimbert will act as topic coordinators for the revision of the rules applied to members of the Management Board and will take into account experience gained with the above policy.
Danish: Lisette Tiddens-Engwirda og Jean Marimbert vil fungere som emnekoordinatorer for revisionen af de bestemmelser, der finder anvendelse på bestyrelsens medlemmer, og vil tage højde for erfaringerne med denne strategi.
English: The hearing addressed such topics as coordination of procurement of vaccines, adequacy of the mechanisms to declare a pandemic, risk assessment, arrangements to manage of conflicts of interest and other.
Danish: Høringen vedrørte emner som koordination af vaccineindkøb, egnethed af mekanismerne til erklæring af en pandemi, risikovurdering, ordninger til håndtering af interessekonflikter mv.
English: It was suggested that, in future, an agreement with the industry on the format of marketing authorisation applications in a way that would facilitate access without the need for redacting of commercial confidential and information containing personal data throughout the document should be explored.
Danish: Det blev foreslået, at der i fremtiden bliver søgt indgået en aftale med industrien om formatet af ansøgninger om markedsføringstilladelser på en måde, der letter adgangen, uden at det er nødvendigt at anføre kommercielt fortrolige oplysninger og personoplysninger i hele dokumentet.
English: The Board discussed that in future information about signal management activities will need to be provided.
Danish: Bestyrelsen argumenterede for, at der for fremtiden skal indsendes oplysninger om signalstyringsaktiviteter.
English: The Management Board provided comments with regards to the reasons for the decline in the number of applications for human medicinal products, the increase in applications for paediatric investigation plans and the previous discussions of the Board on the payment system to national competent authorities.
Danish: Bestyrelsen fremsatte kommentarer om grundene til faldet i antallet af ansøgninger om humanlægemidler, stigningen i antallet af ansøgninger om pædiatriske undersøgelsesplaner og bestyrelsens tidligere drøftelser om systemet til betaling af de kompetente nationale myndigheder.
English: The topic coordinators will continue to work with the Agency on this matter which is expected to be ready for the decision by the end of 2010 or beginning of 2011.
Danish: Emnekoordinatorerne vil fortsat arbejde sammen med agenturet i denne sag, og der forventedes truffet en beslutning i sagen i slutningen af 2010 eller i starten af 2011.
English: An international workshop in the area of GCP and ethical requirements for clinical trials
Danish: International workshop om GCP-aspekter og etiske aspekter ved kliniske forsøg
English: The Board also agreed to the proposal that the Chair of the Management Board will be invited to attend one meeting of the AAC per year and the Chair of the Committee will be invited to attend one meeting of the Board per year.
Danish: Bestyrelsen godkendte ligeledes forslaget om, at formanden for bestyrelsen en gang om året vil blive indbudt til at deltage i et af det rådgivende revisionsudvalgs møder, og at udvalgets formand en gang om året vil blive indbudt til at deltage i et af bestyrelsens møder.
English: The Management Board was given a presentation on the current options available to the Agency in respect of its future accommodation and the criteria applied to evaluate the options.
Danish: Bestyrelsen fik præsenteret agenturets aktuelle muligheder med hensyn til dets fremtidige lokaler og de kriterier, der skulle finde anvendelse i forbindelse med vurderingen af disse muligheder.
English: In addition to the annual report, any other reports from the AAC will be presented to the Board.
Danish: Ligesom årsberetningen vil også alle øvrige rapporter fra det rådgivende revisionsudvalg blive forelagt bestyrelsen.
English: The Agency will publish a summary report with slides on the meeting and will finalise the paper in 2011.
Danish: Agenturet vil offentliggøre et sammenfattende referat med diasshow på mødet og færdiggøre dokumentet i 2011.
English: The amendments concerns extensions of marketing authorisation, Type II variations, annual fees, variations to plasma master files and vaccine antigen master files.
Danish: Ændringerne vedrørte udvidelser af markedsføringstilladelser, ændringer af type II, årlige gebyrer, ændringer i masterfiler vedrørende plasma og masterfiler vedrørende vaccineantigener.
English: • Nomination form and CV for the nomination to the CVMP
Danish: • Ansøgningsformular og CV vedrørende udnævnelsen til CVMP
English: Nomination to the CVMP
Danish: Udnævnelse til CVMP
English: In the context of the Management Board consultation procedure on nominations to the scientific committees, the Board discussed the level of scientific competence of nominees to the committees and the desired scientific and regulatory qualifications and experience of members.
Danish: I forbindelse med bestyrelsens høringsprocedure om udnævnelser til de videnskabelige udvalg drøftede bestyrelsen udvalgskandidaternes videnskabelige kompetenceniveau og de for medlemmerne ønskede reguleringsmæssige kvalifikationer og erfaringer.
English: Following the request from the Spanish Member of the Board, the Members noted the Draft Council conclusions on Innovation and Solidarity in the Pharmaceutical Sector prepared by the Presidency.
Danish: På foranledning af bestyrelsens spanske medlem noterede medlemmerne sig forslaget til Rådets konklusioner om innovation og solidaritet i lægemiddelsektoren, som formandskabet havde udarbejdet.
English: The Board stressed that a collective approach to transparency of the decision making process is needed in the network.
Danish: Bestyrelsen understregede, at der er behov for en kollektiv tilgang i netværket til gennemsigtighed i beslutningsprocessen.
English: The publication will take place after the official announcement has been made.
Danish: Dokumentet vil blive offentliggjort efter det officielle opslag.
English: • [EMA/496888/2010] Update report on the Agency's implementation of the EU telematics strategy
Danish: • [EMA/496888/2010] Ajourført rapport om agenturets gennemførelse af EU's telematikstrategi
English: Audit Advisory Committee contribution paper to the Management Board
Danish: Det rådgivende revisionsudvalgs indberetning til bestyrelsen
English: The Board discussed that transparency of deliberations leading to the decision need to be improved and more information has to be provided to the public at different stages of the decision.
Danish: Bestyrelsen argumenterede for, at gennemsigtigheden af de forhandlinger, der er afgørende for beslutningstagningen, skal forbedres, og at offentligheden skal underrettes mere indgående på forskellige stadier af beslutningstagningen.
English: The Management Board adopted the procedure for the selection of the Executive Director.
Danish: Bestyrelsen vedtog proceduren for udvælgelse af den administrerende direktør.
English: [EMA/MB/531926/2010] The Management Board discussed the issue raised in the report by the Health Action International which suggested that not all patient and consumer organisations fulfil the Agency's financial transparency criteria.
Danish: [EMA/MB/531926/2010] Bestyrelsen drøftede spørgsmålet, som var blevet rejst i Health Action Internationals rapport, af hvilken det fremgik, at ikke alle patient- og forbrugerorganisationer opfyldte agenturets kriterier vedrørende finansiel gennemsigtighed.
English: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway) Apology received from Iceland
Danish: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norge) Afbud fra Island
English: The Board endorsed the AAC approach to its remit in March 2005.
Danish: Bestyrelsen godkendte tilgangen med et rådgivende revisionsudvalg under dens kompetenceområde i marts 2005.
English: • Presentation on the EMA accommodation strategy
Danish: • Præsentation af EMA's kontorlokalestrategi
English: Revised policy on the handing of conflicts of interests
Danish: Revideret strategi for håndtering af interessekonflikter
English: A number of Board members felt that, while the final decision on appointment of a member lies with the Member State in accordance with Art. 61 of Regulation (EC) No 726/2004, only appropriately scientifically qualified members should be accepted.
Danish: Flere bestyrelsesmedlemmer mente, at mens den endelige afgørelse om udpegelse af medlemmer i henhold til artikel 61 i forordning (EF) nr. 726/2004
English: Amongst further activities, the Agency plans to revise the “Framework of Interaction” between the EMA and PCOs and to explore how patients and consumers can be involved in the benefit/risk assessment of medicinal products.
Danish: Agenturet agtede bl.a. at revidere rammen for samspil mellem EMA og patient- og forbrugerorganisationerne og at undersøge, hvordan patienter og forbrugere kan inddrages i vurderingen af fordele/risici ved lægemidler.
English: • The final English version of the announcement for the selection procedure for the Executive
Danish: • Den endelige engelske udgave af opslaget vedrørende proceduren for udvælgelse af den administrerende direktør
English: Future accommodation of the Agency
Danish: Agenturets fremtidige lokaler
English: [EMA/MB/575243/2010] The Executive Director had established the Audit Advisory Committee to oversee and advice him on internal controls, financial and risk management, and audits in order to help secure good governance and effective accountability and transparency.
Danish: [EMA/MB/575243/2010] Den administrerende direktør havde nedsat et rådgivende revisionsudvalg til at føre tilsyn med og rådgive ham om intern kontrol, finansiel styring og risikostyring samt revision med henblik på at sikre god forvaltningspraksis og effektive mekanismer med hensyn til redegørelsespligt og gennemsigtighed.
English: The organisations are also subject to regular re-evaluation of their eligibility.
Danish: Organisationernes berettigelse revurderes regelmæssigt.
English: [EMA/MB/603657/2010] The Management Board adopted the transfer of € 4.4 million of ‘provisional appropriation' (€ 5.4 million) that was set aside for possible variations in fee income.
Danish: [EMA/MB/603657/2010] Bestyrelsen vedtog overførslen af 4,4 mio. EUR af den "formålsbestemte reserve" (5,4 mio. EUR), der var afsat til mulige afvigelser i indtægten fra gebyrer.
English: [EMA/MB/575364/2010] The Management Board noted the proposal for a written procedure for the adoption of the aforementioned policy which will be launched after the Agency receives the opinion of the European Data Protection Supervisor.
Danish: [EMA/MB/575364/2010] Bestyrelsen noterede sig forslaget om en skriftlig procedure for vedtagelse af ovennævnte strategi, som ville blive iværksat af agenturet, når det havde modtaget udtalelsen fra Den Europæiske Tilsynsførende for Databeskyttelse.
English: [EMA/MB/398075/2010] The agenda was adopted with the following item added: Draft Council conclusions on innovation and solidarity in the pharmaceutical sector.
Danish: [EMA/MB/398075/2010] Dagsordenen blev vedtaget med tilføjelse af følgende punkt: Forslag til Rådets konklusioner om innovation og solidaritet i lægemiddelsektoren.
English: Third report on the progress of the interaction with Patients' and Consumers' Organisations during 2009
Danish: Tredje rapport om fremgangen i samspillet med patient- og forbrugerorganisationer i
English: • The HMA's endorsement of the draft Memorandum of Understanding on the monitoring of the scientific level and independence of the evaluation carried out by the NCAs for the Agency.
Danish: • Cheferne for de nationale lægemiddelstyrelsers godkendelse af udkastet til aftalememorandum om overvågningen af det videnskabelige niveau og uafhængigheden af de vurderinger, som de kompetente nationale myndigheder udfører for agenturet.
English: • [EMA/MB/539466/2010] MBTC's Telematics Implementation Group: Chair's appointment procedure and role
Danish: • [EMA/MB/539466/2010] MBTC's telematikimplementeringsgruppe: procedure for valg af formand og dennes rolle
English: Update from the group of chairs of EU agencies
Danish: Opdatering fra EU-agenturernes formænd
English: • [EMA/MB/528844/2010] Summary of transfers of appropriations in the budget 2010.
Danish: • [EMA/MB/528844/2010] Sammendrag af bevillingsoverførsler på budgettet for 2010
English: • [EMA/MB/535239/2010] Outcome of written procedures during the period from 7 June 2010 to
Danish: • [EMA/MB/535239/2010] Resultat af skriftlige procedurer i perioden fra den 7. juni 2010 til den 4.
English: [EMA/MB/578243/2010] Taking into account that a new Executive Director will not be selected in time to take office from 1 January 2011, the Board discussed the appointment of an acting Executive Director and recommended the appointment of Andreas Pott, Head of Administration.
Danish: Udnævnelse af den fungerende administrerende direktør [EMA/MB/578243/2010] Da der ikke vil blive udnævnt en ny administrerende direktør tidsnok til, at denne kan tiltræde stillingen pr. 1. januar 2011, drøftede bestyrelsen udnævnelsen af en fungerende administrerende direktør og anbefalede Andreas Pott, leder af administrationsafdelingen, til stillingen.
English: Resource consequences, should new responsibilities be granted, need to be examined.
Danish: Hvis agenturet får tildelt nye ansvarsområder, skal de ressourcemæssige følger heraf undersøges.
English: The proposal received a favourable opinion from the European Commission.
Danish: Forslaget fik Europa-Kommissionens tilslutning.
English: Consumers' Organisations (PCOs) during 2009 and includes information about the status of implementation of the actions and recommendations that were identified in previous reports.
Danish: Dokumentet indeholdt oplysninger om status for gennemførelsen af de tiltag og anbefalinger, der var blevet identificeret i de tidligere rapporter.
English: • Presentation on the EMA Policy on the Handling of Conflicts of Interest for Scientific Committee
Danish: • Præsentation af EMA's strategi for håndtering af interessekonflikter hos medlemmer af de videnskabelige udvalg og eksperter
English: 4 October 2010.
Danish: oktober 2010
English: The Agency's transparency policy due to be finalised next year will address this aspect.
Danish: Der vil blive set på dette aspekt i forbindelse med fastlæggelsen af agenturets gennemsigtighedsstrategi næste år.
English: 2009 EudraVigilance Human Status Report 2009
Danish: Statusrapport om EudraVigilance i 2009 - lægemidler til mennesker
English: [EMA/MB/818152/2009] The Management Board adopted the amendments to the implementing rules on the Agency's fees.
Danish: [EMA/MB/818152/2009] Bestyrelsen vedtog ændringerne af gennemførelsesbestemmelserne om agenturets gebyrer.
English: 16 December 2010 EMA/MB/628133/2010
Danish: 16. december 2010 EMA/440456/2011
English: [EMA/MB/528780/2010; EMA/MB/216485/2009; EMA/MB/281870/2010] The Management Board adopted the revised EMA Financial Regulation and implementing rules.
Danish: [EMA/MB/528780/2010; EMA/MB/216485/2009; EMA/MB/281870/2010] Bestyrelsen vedtog den reviderede finansforordning for EMA og dens gennemførelsesbestemmelser.
English: Held in London on 7 October 2010
Danish: møde i London den 7. oktober 2010
English: [EMA/MB/568706/2010] The Management Board adopted the proposed revision to the Agency's internal control standard on sensitive functions.
Danish: [EMA/MB/568706/2010] Bestyrelsen vedtog den foreslåede revision af agenturets interne kontrolstandard vedrørende følsomme stillinger.
English: Amendments to Fees payable to the European Medicines Agency and other measures
Danish: Revision af de gebyrer, der skal betales til EMA, og andre foranstaltninger
English: [EMA/MB/559867/2010] The Management Board endorsed the proposal to establish a joint CVMP/CHMP ad-hoc expert group on the application of the 3Rs in the development of medicinal products.
Danish: [EMA/MB/559867/2010] Bestyrelsen godkendte forslaget om nedsættelse af en fælles CVMP/CHMP-ad hoc-ekspertgruppe vedrørende anvendelsen af 3R-princippet i udviklingen af lægemidler.
English: [EMA/MB/404038/2010] The Management Board noted the final minutes, adopted by written procedure on 4 August 2010.
Danish: møde den 10. juni 2010 [EMA/MB/404038/2010] Bestyrelsen noterede sig det endelige referat, der blev vedtaget gennem den skriftlige procedure den 4. august 2010.
English: The Board was informed that contacts were established with the European Commission on the matter.
Danish: Bestyrelsen blev underrettet om, at Europa-Kommissionen var blevet inddraget i sagen.
English: [EMA/MB/599720/2010] The Management Board endorsed the EudraVigilance status report for Human medicinal products for 2009.
Danish: [EMA/MB/599720/2010] Bestyrelsen godkendte statusrapporten om EudraVigilance i 2009 om lægemidler til mennesker.
English: Minutes of the 68th meeting of the Management Board
Danish: Referat af bestyrelsens 68.
English: [EMA/MB/588579/2010; EMA/MB/589332/2010] The Management Board endorsed the Agency's updated policy on the handling of conflicts of interests of Scientific Committee members and experts, and noted the document providing an overview of the allowable interests for the EMA scientific activities.
Danish: [EMA/MB/588579/2010; EMA/MB/589332/2010] Bestyrelsen godkendte agenturets ajourførte strategi for håndtering af interessekonflikter hos medlemmer af de videnskabelige rådgivende grupper og eksperter og noterede sig det dokument, der gav et overblik over de interesser, som kunne tillades i forbindelse med EMA's videnskabelige aktiviteter.
English: Representative of veterinarians' organisations
Danish: Repræsentant for dyrlægeorganisationer
English: [EMA/MB/578660/2010] The Board noted the nomination to the CVMP.
Danish: [EMA/MB/578660/2010] Bestyrelsen noterede sig udnævnelsen til CVMP.
English: [EMA/MB/579729/2010] The Management Board noted the report.
Danish: [EMA/MB/579729/2010] Bestyrelsen noterede sig rapporten.
English: [EMA/MB/511582/2010] The Management Board noted the mid-year report 2010.
Danish: [EMA/MB/511582/2010] Bestyrelsen noterede sig halvårsrapporten 2010.
English: [EMA/MB/577848/2010; EMA/577855/2010] The Management Board endorsed the annual report on the operation of the Minor Use Minor Species (MUMS) policy and the proposal to continue with the scheme for an additional year.
Danish: [EMA/MB/577848/2010; EMA/577855/2010] Bestyrelsen godkendte årsberetningen om anvendelse af MUMS-politikken (Minor Use Minor Species) og forslaget om at lade ordningen køre videre endnu et år.
English: The document describes the on going progress of the interaction between the European Medicines Agency and Patients' and
Danish: I dokumentet blev den aktuelle fremgang i samspillet mellem Det Europæiske Lægemiddelagentur og patient- og forbrugerorganisationerne i 2009 beskrevet.
English: [EMA/MB/400828/2009] The Board noted that the vacancy notice for the selection of the Executive Director of the EMA will be published on 27 October 2010 with a closing date for applications on 24 November 2010.
Danish: Bestyrelsens procedure i forbindelse med udvælgelse af den administrerende direktør [EMA/MB/400828/2009] Bestyrelsen bemærkede, at stillingsopslaget om udvælgelse af den administrerende direktør for EMA vil blive offentliggjort den 27. oktober 2010, og at ansøgningsfristen vil blive den 24. november 2010.
English: meeting on 26 October.
Danish: møde i London den 7. oktober
English: • The upcoming meeting with the European Generics Association (EGA) in the margins of the HMA
Danish: • Det forestående møde med European Generic Medicines Association (EGA) i forbindelse med mødet mellem cheferne for de nationale lægemiddelstyrelser den 26. oktober.
English: [EMA/MB/581808/2010; EMA/MB/581875/2010] The Management Board endorsed the EMA Policy on access to documents (related to medicinal products for human and veterinary use) and noted the document outlining outputs of the policy.
Danish: [EMA/MB/581808/2010; EMA/MB/581875/2010] Bestyrelsen vedtog EMA's politik for aktindsigt (i forbindelse med lægemidler til mennesker og dyr) og noterede sig det dokument, der skitserede politikkens resultater.
English: Executive Director briefed the Management Board about the hearing at the European Parliament.
Danish: Europa-Parlamentets høring om H1N1-pandemien Den administrerende direktør underrettede bestyrelsen om Europa-Parlamentets høring.
English: Doctors' organisations to Commissioner John Dallli on the proposed revised EMA Policy on the
Danish: • Skrivelse fra Europa-Parlamentets repræsentant i bestyrelsen og repræsentanten for lægeorganisationerne til kommissær John Dalli om den foreslåede reviderede EMA-strategi for håndtering af interessekonflikter hos medlemmer af de videnskabelige udvalg og eksperter
English: List of participants at the 68th meeting of the Management Board, held in London, 7 October 2010
Danish: Liste over deltagere ved bestyrelsens 68.
English: AOB
Danish: Afbud
English: Access to documents
Danish: Aktindsigt
English: Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008
Danish: Resultatet af en procedure i henhold til artikel 13 i forordning (EF) nr. 1234/2008
English: The company applied for a change (variation) to the marketing authorisation to add a new indication to be recognised by Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Danish: Virksomheden ansøgte om en ændring af markedsføringstilladelsen med henblik på at tilføje en ny indikation, som skal anerkendes af Belgien, Bulgarien, Cypern, Danmark, Estland, Finland, Det Forenede Kongerige, Frankrig, Grækenland, Irland, Island, Italien, Letland, Litauen, Luxembourg, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige, Tjekkiet, Ungarn og Østrig (de "berørte medlemsstater").
English: The company that markets the product is Bayer Vital GmbH.
Danish: Virksomheden, der markedsfører produktet, er Bayer Vital GmbH.
English: Why was Seresto reviewed?
Danish: Hvorfor blev Seresto vurderet igen?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25 May 2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25.
English: Seresto is authorised in the European Union (EU) under the decentralised procedure with Germany as the reference Member State.
Danish: Seresto er tilladt i Den Europæiske Union (EU) i henhold til den decentrale procedure med Tyskland som referencemedlemsstat.