FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, by providing a high dose in a single tablet Neofordex was expected to simplify dosing.
Danish: Desuden forventedes Neofordex at gøre det enklere at tage medicinen, fordi det indeholder en høj dosis i én enkelt tablet.
English: Because Neofordex was assessed as a hybrid medicine, and the effects of high-dose dexamethasone in multiple myeloma are well established, the company presented the results of a study carried out to investigate whether it is bioequivalent to the reference medicine, Dectancyl.
Danish: Neofordex blev vurderet som et hybridt lægemiddel, og virkningen af høje doser af dexamethason ved multipelt myelom er anerkendt.
English: In multiple myeloma, high-dose
Danish: Ved multipelt myelom anvendes dexamethason i
English: Annex IV Condition for lifting the suspension of the marketing authorisations
Danish: Bilag IV Betingelse for ophævelse af suspenderingen af markedsføringstilladelserne
English: For the suspension to be lifted, National competent authorities of Member States or reference Member States, if applicable, shall ensure that the following condition is fulfilled by the MAHs:
Danish: For at suspenderingen kan ophæves, sikrer de kompetente nationale myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaterne, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser:
English: The MAHs should appropriately reformulate the product taking into account its misuse potential.
Danish: Indehaverne af markedsføringstilladelserne omformulerer lægemidlet på passende måde under hensyn til dets misbrugspotentiale.
English: Conditions for lifting the suspension of the marketing authorisations for methadone oral solutions containing povidone
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne for orale metadonopløsninger indeholdende povidon
English: The Agency will facilitate these efforts.
Danish: Agenturet vil fremme disse bestræbelser.
English: 13 April 2016 EMA/363479/2015
Danish: Den 13. april 2016 EMA/389895/2016
English: Draft agenda and list of speakers
Danish: Forslag til dagsorden og liste over talere
English: Early consideration is necessary to allow sufficient time to organise the meeting.
Danish: Tidlige overvejelser er nødvendige for at sikre tilstrækkelig tid til at tilrettelægge mødet.
English: The Agency aims to allocate 10 minutes per person.
Danish: Agenturet sigter mod at tildele hver person ti minutter.
English: In such case no prior registration is required.
Danish: I så fald kræves der ingen forudgående tilmelding.
English: Public hearings at the PRAC - a definition
Danish: Offentlige høringer i PRAC - en definition
English: Language regime
Danish: Sprogordning
English: He or she will be assisted by Agency staff on any administrative and organisational issues.
Danish: Han eller hun vil blive bistået af agenturets personale i forbindelse med eventuelle administrative og organisatoriske spørgsmål.
English: Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)
Danish: Procedureregler for tilrettelæggelsen og gennemførelsen af offentlige høringer i Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC)
English: Legal basis
Danish: Retsgrundlag
English: • Name of the individual.
Danish: • personens navn
English: The PRAC Chair gives the floor to the speakers.
Danish: PRAC's formand giver ordet til talerne.
English: He or she shall also receive the reasons why the request has not been accepted.
Danish: Vedkommende orienteres også om grundene til, at anmodningen ikke er blevet imødekommet.
English: The Agency processes personal data in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data.
Danish: Agenturet behandler personoplysninger i overensstemmelse med Europa-Parlamentets og Rådets forordning (EF) nr. 45/2001 af 18. december 2000 om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger i fællesskabsinstitutionerne og -organerne og om fri udveksling af sådanne oplysninger.
English: • A summary of the safety concern.
Danish: • et resumé af sikkerhedsbekymringerne
English: The requester should also clearly indicate whether he or she intends to participate in person or whether the intervention will be made via teleconference.
Danish: Den anmodende bør også klart angive, om denne agter at deltage personligt, eller om indlægget skal fremsættes via telekonference.
English: • Contact information (postal address, e-mail address, telephone number).
Danish: • kontaktoplysninger (postadresse, e-mailadresse, telefonnummer)
English: • Speakers can make an intervention in person or via teleconferencing facilities (Adobe Connect) where possible and feasible (See section 3.3 for more information on how to submit a request to participate as a speaker).
Danish: • Talerne kan fremsætte et indlæg personligt eller via telekonference (Adobe Connect), når det er muligt og gennemførligt (se punkt 3.3 for flere oplysninger om, hvordan man kan indgive en anmodning om at deltage som taler).
English: Key principles
Danish: Hovedprincipper
English: The Agency cannot be held liable for any expenses occurred in case of cancellation.
Danish: Agenturet kan ikke holdes ansvarligt for eventuelle udgifter i forbindelse med aflysningen.
English: However, if they do wish to be present in the room, they must register in advance.
Danish: Hvis de ønsker at være til stede i lokalet, skal de dog tilmelde sig på forhånd.
English: Speakers should be aware that they have a fixed maximum time to make their intervention.
Danish: Talerne bør være opmærksomme på, at de har en fast maksimumstid til at fremsætte deres indlæg.
English: However, the PRAC continues to have the sole responsibility for giving its scientific recommendation on the safety of the medicine(s) concerned.
Danish: PRAC har dog fortsat eneansvaret for at afgive sine videnskabelige anbefalinger om sikkerheden i forbindelse med det (de) pågældende lægemiddel (lægemidler).
English: Participation requests should be sent in writing to the Agency using a dedicated form and should include the following information:
Danish: Anmodninger om deltagelse bør sendes skriftligt til agenturet ved hjælp af en særlig formular og indeholde følgende oplysninger:
English: Members of the public can participate actively, as speakers, or they can opt to participate as observers.
Danish: Borgerne kan deltage aktivt som talere, eller de kan vælge at deltage som observatører.
English: • Potential impact of possible regulatory actions on therapeutic practice and availability of treatments.
Danish: • eventuelle lovgivningsmæssige foranstaltningers potentielle virkning på den terapeutiske praksis og tilgængeligheden af behandlinger
English: Arrangements to be put in place for such non-public hearings fall outside the scope of these rules of procedure.
Danish: De foranstaltninger, der skal træffes for sådanne ikkeoffentlige høringer, er ikke omfattet af disse procedureregler.
English: The Agency will endeavour to accommodate all speaking requests.
Danish: Agenturet vil bestræbe sig på at imødekomme alle anmodninger om at tale.
English: The time the Agency allocates to each speaker is dependent upon the number of requests received.
Danish: Den tid, agenturet tildeler hver enkelt taler, afhænger af antallet af modtagne anmodninger.
English: If they are unable to present in English, the European Medicines Agency (hereafter referred to as “Agency”) will provide translation from the official EU languages into English.
Danish: Hvis de ikke kan fremlægge deres indlæg på engelsk, vil Det Europæiske Lægemiddelagentur (herefter "agenturet") sørge for oversættelse fra de officielle EU-sprog til engelsk.
English: The Committee shall endeavour to reach agreement on holding a public hearing by consensus.
Danish: Udvalget vil bestræbe sig på at nå til enighed om at afholde en offentlig høring ved konsensus.
English: The assessment report will be made public once the decision-making process has been finalised.
Danish: Vurderingsrapporten vil blive offentliggjort, når beslutningsprocessen er afsluttet.
English: In the public hearing, due regard shall be given to the therapeutic effect of the medicinal product.
Danish: I forbindelse med offentlige høringer tages der behørigt hensyn til lægemidlets terapeutiske virkning.
English: At the start of each referral the PRAC will consider the need to hold a public hearing as described in section 2.2.
Danish: Ved begyndelsen af hver indbringelse vil PRAC overveje behovet for at afholde en offentlig høring som beskrevet i punkt 2.2.
English: Modalities of participation
Danish: Former for deltagelse
English: The legal basis for holding public hearings in the defined procedures is Article 107j of Directive 2001/83/EC:
Danish: Retsgrundlaget for afholdelsen af offentlige høringer i forbindelse med de fastlagte procedurer er artikel 107j i direktiv 2001/83/EF:
English: Further information is provided on the Agency's website under “Privacy statement”.
Danish: Yderligere oplysninger gives på agenturets websted under "Privacy statement".
English: These requests will only be accommodated if space permits.
Danish: Disse anmodninger vil kun blive imødekommet, hvis der er plads.
English: • Level of public interest.
Danish: • omfanget af offentlighedens interesse.
English: Impact on PRAC opinion
Danish: Indvirkning på PRAC's holdning
English: Speakers will be alerted when their allocated time has nearly expired.
Danish: Talerne vil blive advaret, når deres taletid er næsten udløbet.
English: In situations where it is not feasible for the Agency to reschedule the public hearing, the Agency will announce on its website the modalities for receiving written contributions.
Danish: I situationer, hvor det ikke er muligt for agenturet at planlægge en ny offentlig høring, vil agenturet på sit websted bekendtgøre reglerne for at modtage skriftlige bidrag.
English: Media organisations who wish to cover the public hearing may attend as observers.
Danish: Medieorganisationer, der ønsker at dække den offentlige høring, kan deltage som observatører.
English: The announcement is published on the Agency's website1, together with:
Danish: Bekendtgørelsen offentliggøres på agenturets websted1 sammen med:
English: If the PRAC cannot reach an agreement by consensus, the decision is taken by vote as provided for in the PRAC rules of procedure.
Danish: Hvis dette ikke lykkes for PRAC, træffes beslutningen ved afstemning som fastsat i PRAC's forretningsorden.
English: The Committee can reconsider its previous decision not to hold a public hearing during the course of the referral procedure, on the basis of new information.
Danish: Udvalget kan tage sin tidligere beslutning om ikke at afholde en offentlig høring i løbet af indbringelsesproduceren op til fornyet overvejelse på grundlag af nye oplysninger.
English: Public hearings can add various elements to the considerations of the PRAC.
Danish: Offentlige høringer kan føje adskillige elementer til overvejelserne i PRAC.
English: • Information about live-broadcast/web stream.
Danish: • oplysninger om direkte transmission/webstreaming.
English: The PRAC Chair can also stop a speaker if his or her intervention does not address the questions asked by the PRAC or if the speaker does not adhere to the general ground rules.
Danish: Formanden for PRAC kan også stoppe en taler, hvis vedkommendes indlæg ikke tager de spørgsmål op, som PRAC har stillet, eller hvis taleren ikke overholder de almindelige grundregler.
English: Modalities of participation in a public hearing therefore include the following:
Danish: Muligheder for at deltage i en offentlig høring omfatter derfor følgende:
English: • Capacity (i.e. whether the person is speaking as a patient or carer, a healthcare professional, an academic or a representative of the pharmaceutical industry, irrespective of whether the person speaks as an individual or a representative of an organisation/pharmaceutical company).
Danish: • status (dvs. om personen taler som patient eller behandler, sundhedsperson, akademiker eller repræsentant for lægemiddelindustrien, uanset om personen taler som enkeltperson eller repræsentant for en organisation/lægemiddelvirksomhed)
English: The order and time available for each intervention is determined in the agenda.
Danish: Talerordenen og taletiden for hvert indlæg fremgår af dagsordenen.
English: • A list of specific questions on which information from the public is sought during the public hearing.
Danish: • en liste over specifikke spørgsmål, hvorom der søges oplysninger fra offentligheden under høringen
English: Requests for participation as an observer at the public hearing should also be sent to the Agency.
Danish: Anmodninger om deltagelse som observatør i en offentlig høring bør også sendes til agenturet.
English: • Therapeutic effect of the medicine/class of medicines and availability of therapeutic alternatives.
Danish: • den terapeutiske virkning af lægemidlet/gruppen af lægemidler og tilstedeværelsen af terapeutiske alternativer
English: The marketing authorisation holder(s) has/have the opportunity to present its/their view(s) to the participants of the public hearing.
Danish: Indehaver(en)(ne) af markedsføringstilladelsen har mulighed for at redegøre for sit (sine)/deres synspunkt(er) over for deltagerne i den offentlige høring.
English: If the speaker does not conclude his or her intervention after being asked to do so, the microphone may be turned off.
Danish: Hvis taleren ikke afslutter sit indlæg efter denne henstilling, kan mikrofonen blive slukket.
English: He or she states the purpose of the public hearing and presents the order of the day and operational aspects for the meeting.
Danish: Han eller hun anfører formålet med den offentlige høring og redegør for dagsordenen og de operationelle aspekter af mødet.
English: Each speaker will be asked to briefly introduce himself or herself, clearly state their name and the organisation/group the speaker represents, where applicable, and to declare any interests related to the medicinal products/medicinal substances, including their competitors, discussed at the meeting.
Danish: Hver taler vil blive bedt om kort at præsentere sig, klart nævne sit navn og den organisation/gruppe, som taleren repræsenterer, hvis det er relevant, og erklære eventuelle interesser i relation til lægemidlerne/lægemiddelstofferne, herunder deres konkurrenter, som drøftes på mødet.
English: • A brief outline of the planned intervention, specifically how it addresses the questions on which the PRAC is seeking public opinion and the estimated amount of time requested for the presentation.
Danish: • en kort redegørelser for det planlagte indlæg, navnlig hvordan det tager de spørgsmål op, som PRAC ønsker offentlighedens mening om, og indlæggets anslåede varighed.
English: • Feasibility to hold a public hearing in light of the urgency of the matter.
Danish: • muligheden for at afholde en offentlig høring set i lyset af sagens hastende karakter
English: Cancellation
Danish: Aflysning
English: All public hearings will be conducted in English.
Danish: Alle offentlige høringer vil blive afviklet på engelsk.
English: • Nature and extent of the safety concern.
Danish: • sikkerhedsbekymringens karakter og omfang
English: Submitting a request to attend as observer
Danish: Indgivelse af en anmodning om deltagelse som observatør
English: • Where relevant, request for the provision of translation in case of attendance as a speaker, including information on which official EU language should be translated into English.
Danish: • når det er relevant, anmodning om oversættelse i tilfælde af deltagelse som taler, herunder oplysninger om, hvilket officielt EU-sprog der skal oversættes til engelsk.
English: The PRAC Chair, in collaboration with Agency staff, is responsible for the preparation of the public hearing and the conduct of the public hearing and shall take appropriate measures to ensure that the public hearing is run effectively and efficiently.
Danish: Formanden for PRAC er i samarbejde med agenturets personale ansvarlig for at forberede og afvikle den offentlige høring og træffer passende foranstaltninger til at sikre, at den offentlige høring gennemføres målrettet og effektivt.
English: Participants are encouraged to use English during the public hearing.
Danish: Deltagerne opfordres til at bruge engelsk ved den offentlige høring.
English: The PRAC has the possibility to hold public hearings in the context of safety referral procedures under Article 20 of Regulation (EC) 726/2004, Article 31 or Article 107i of Directive 2001/83/EC.
Danish: PRAC har mulighed for at afholde offentlige høringer i forbindelse med indbringelsesprocedurer baseret på sikkerhedsbekymringer i henhold til artikel 20 i forordning (EF) 726/2004, artikel 31 eller artikel 107i i direktiv 2001/83/EF.
English: Interventions
Danish: Indlæg
English: For organisational reasons, participants must register in advance.
Danish: Af organisatoriske grunde skal deltagerne tilmelde sig på forhånd.
English: Where a marketing authorisation holder or another person intending to submit information has confidential data relevant to the subject matter of the procedure, he may request permission to present that data to the Pharmacovigilance Risk Assessment Committee in a non-public hearing.”
Danish: Hvis en indehaver af en markedsføringstilladelse eller en anden person, som ønsker at forelægge oplysninger, har fortrolige oplysninger, der er relevante for forholdet, kan vedkommende anmode om at få lov til at forelægge disse oplysninger for Udvalget for Risikovurdering inden for Lægemiddelovervågning i en ikkeoffentlig høring."
English: 1 The Agency's website will serve as the European medicines webportal until further notice.
Danish: 1 Agenturets websted fungerer indtil videre som webportal for europæiske lægemidler.
English: The Agency shall, in consultation with the parties concerned, draw up rules of procedure on the organisation and conduct of public hearings, in accordance with Article 78 of Regulation (EC) No
Danish: Agenturet udarbejder i samråd med de berørte parter regler for proceduren vedrørende tilrettelæggelsen og gennemførelsen af offentlige høringer i overensstemmelse med artikel 78 i forordning (EF) nr. 726/2004.
English: Public hearings are open to all members of the public.
Danish: Offentlige høringer er tilgængelige for alle medlemmer af offentligheden.
English: The interests declared will be minuted in the meeting record.
Danish: De erklærede interesser vil blive anført i mødereferatet.
English: However, each individual who has not been admitted as a speaker has the right to submit, prior to the public hearing, a written statement for consideration by the PRAC.
Danish: Enhver person, der ikke er blevet godkendt som taler, har dog ret til forud for den offentlige høring at indgive en skriftlig erklæring til PRAC til overvejelse.
English: • Registration information, including the deadline by which participants can register to attend the hearing as speakers or observers.
Danish: • oplysninger om tilmelding, herunder fristen for deltagernes tilmelding med henblik på deltagelse i høringen som taler eller observatør
English: The information submitted to the Agency will be made public for all participants who make an intervention at the public hearing, with the exception of any personal contact details.2
Danish: De oplysninger, der sendes til agenturet, vil blive offentliggjort for alle deltagere, der fremlægger et indlæg under den offentlige høring, undtagen eventuelle personlige kontaktoplysninger2.
English: The hearings shall be held in accordance with the modalities specified by the Agency and shall be announced by means of the European medicines web-portal.
Danish: Høringerne afholdes i overensstemmelse med de nærmere bestemmelser herfor som fastlagt af agenturet og meddeles via den europæiske webportal om lægemidler.
English: The value of a public hearing is considered to be greater in that phase of the process where the PRAC has assessed the scientific evidence coming from different sources and where different regulatory options to manage and/or minimise risks are to be considered in a wider public health context, before reaching its conclusion.
Danish: Værdien af en offentlig høring anses for at være større i denne fase af processen, hvor PRAC har vurderet den videnskabelige dokumentation fra forskellige kilder, og hvor forskellige lovgivningsmæssige muligheder for at styre og/eller minimere risici skal betragtes i en bredere folkesundhedssammenhæng, inden der drages en konklusion.
English: Interventions given by participants at the public hearing should focus on providing responses to the questions asked by the PRAC.
Danish: Indlæg fra deltagerne ved den offentlige høring bør fokusere på at give svar på de spørgsmål, som PRAC har stillet.
English: If the allocated time ends before a speaker has concluded his or her intervention, the PRAC Chair should remind him or her to do so.
Danish: Hvis den tildelte taletid udløber, inden en taler har afsluttet sit indlæg, bør formanden for PRAC henstille til vedkommende om at gøre det.
English: Any requests by a marketing authorisation holder or another person to present in a non-public hearing data, considered confidential, relevant to the subject matter of the procedure should also be made at the time of submitting the request to participate.
Danish: Eventuelle anmodninger fra en indehaver af en markedsføringstilladelse eller en anden person om i forbindelse med en ikkeoffentlig høring at fremlægge data, der anses for fortrolige og relevante for emnet for proceduren, bør også indgives samtidig med indgivelsen af anmodningen om deltagelse.
English: Public hearings will take place as part of meetings of the PRAC, with attendance of the Committee members.
Danish: Offentlige høringer finder sted i forbindelse med møder i PRAC med deltagelse af udvalgets medlemmer.
English: Where the number of requests within a group cannot be accommodated during the time allocated, people interested in speaking at the public hearing are encouraged to team-up among themselves.
Danish: Når et antal anmodninger inden for en gruppe ikke kan imødekommes inden for den tildelte tid, opfordres personer, der er interesserede i at tale ved den offentlige høring, til selv at danne en gruppe.
English: The Agency will prepare a list of speakers and a draft agenda for the public hearing, stating the time allocated to each group of speakers, grouped by capacity, and each speaker within a group.
Danish: Agenturet udarbejder en liste over talere og et forslag til dagsorden for den offentlige høring med angivelse af den tid, der tildeles hver gruppe talere, fordelt efter status, og hver taler inden for en gruppe.
English: Detailed information on how to follow the broadcast will be made available via the Agency's website.
Danish: Detaljerede oplysninger om, hvordan man kan følge transmissionen, vil blive stillet til rådighed via agenturets websted.
English: Specific arrangements will be put in place to allow wide media coverage of the public hearing.
Danish: Der vil blive truffet særlige foranstaltninger for at sikre bred mediedækning af den offentlige høring.
English: For organisational reasons, participants will be asked to register in advance.
Danish: Af organisatoriske grunde vil deltagerne blive bedt om at tilmelde sig på forhånd.
English: • Information on how to ask for the provision of translation from an official EU language into English in case of attendance as a speaker.
Danish: • oplysninger om, hvordan man skal anmode om oversættelse fra et officielt EU-sprog til engelsk i tilfælde af deltagelse som taler
English: Following the opening of the public hearing, the PRAC Rapporteur and/ or PRAC Co-Rapporteur give(s) an overview of the procedure, including the main issues and present(s) the questions on which public input is sought.
Danish: Efter åbningen af den offentlige høring giver PRAC's rapportør og/eller medrapportør(er) en oversigt over sagsforløbet, herunder de vigtigste emner, og fremlægger de spørgsmål, som man ønsker offentlighedens mening om.