natgillin/translations-raw huggingface dataset:
Den for markedsføringen ansvarlige opfordres om muligt til at fremsætte mundtlige eller skriftlige forklaringer.
Whenever practicable, the person responsible for placing the veterinary medicinal product on the market shall be invited to provide oral or written explanations.
Kommissionen udarbejder et udkast til den afgørelse, der skal træffes efter fremgangsmåden i artikel 32.
The Commission shall prepare a draft of the Decision to be taken which shall be adopted in accordance with the procedure laid down in Article 32.
Hvor der skal handles hurtigt for at beskytte menneskers eller dyrs sundhed eller miljøet, kan en medlemsstat på sit område suspendere anvendelsen af et veterinærlægemiddel, som er godkendt i overensstemmelse med denne forordning.
Where urgent action is essential to protect human or animal health or the environment, a Member State may suspend the use on its territory of a veterinary medicinal product which has been authorized in accordance with this Regulation.
Kommissionen undersøger straks den af medlemsstaten anførte begrundelse i henhold til stk. 2 og indleder den i stk. 3 omhandlede procedure.
The Commission shall immediately consider the reasons given by the Member State in accordance with paragraph 2 and shall initiate the procedure provided for in paragraph 3.
En medlemsstat, der h;ir truffet de i stk. 4 omhandlede suspenderende foranstaltninger, kan opretholde dem, indtil en endelig afgørelse er truffet efter fremgangsmåden i stk. 3.
A Member State which has adopted the suspensive measures referred to in paragraph 4 may maintain them in force until such time as a definitive decision has been reached in accordance with the procedure laid down in paragraph 3.
Definitionerne i artikel 42 i direktiv 81/851/EØF finder anvendelse i dette kapitel.
For the purpose of this Chapter, the definitions given in Article 42 of Directive 81/851/EEC shall apply.
Udvalget kan i givet fald i medfør af artikel 27 fremsætte udtalelser om, hvilke foranstaltninger der er nødvendige for at sikre en sikker og effektiv brug af sådanne veterinærlægemidler.
If necessary the Committee may. in accordance with Article 27, formulate opinions on the measures necessary to ensure the safe and effective use of such veterinary medicinal products.
Disse foranstaltninger træffes efter fremgangsmåden i artikel 40.
These measures shall be adopted in accordance with the procedure laid down in Article 40.
Den, der er ansvarlig for markedsføringen af et veterinærlægemiddel, der er godkendt af Fællesskabet i henhold til denne forordning, skal til stadighed have en person, der er tilstrækkeligt sagkyndig inden for lægemiddelovervågning, til sin rådighed
The person responsible for the placing on the market of a veterinary medicinal product authorized by the Community in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.
Denne sagkyndige person er ansvarlig for følgende: a) oprettelse og drift af et system, der sikrer, at oplysninger om alle formodede bivirkninger, der indberettes til virksomhedens personale og konsulenter, samles, vurderes og registreres på en sådan måde, at der er adgang lil dem pä ét enkelt sted i Fællesskabet b) udarbejdelse al" de i artikel 44 omhandlede fortegnelser til de kompetente myndigheder i medlemsstaterne og til agenturet i overensstemmelse med kravene i denne forordning c) sikring af, at eventuelle anmodninger fra de kompetente myndigheder om tilvejebringelse af yderligere oplysninger til vurdering af fordele og risici ved et veterinærlægemiddel besvares hurtigt og fuldstændigt, herunder oplysninger om, hvor stort salget er, eller hvor mange recepter der er udstedt for det pågældende veterinærlægemiddel.
That qualified person shall be responsible for the following: a) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company and to its representatives is collected, evaluated and collated so that it may be accessed at a single point within the Community; b) the preparation of the reports referred to in Article 44 for the competent authorities of the Member States and the Agency in accordance with die requirements of this Regulation; c) ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the benefits and risks of a veterinary medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions for the veterinary medicinal product concerned.
Den for markedsføringen ansvarlige sikrer, at alle formodede alvorlige bivirkninger, som i Fællesskabet har manifesteret sig ved et i medfør af denne forordning godkendt veterinærlægemiddel, og som han er gjort opmærksom på, registreres og straks eller i hvert fald senest 15 dage efter, at han har modtaget oplysningen, indberettes til de medlemsstater, på hvis område hændelsen er indtruffet.
The person responsible for placing a veterinary medicinal product on the market shall ensure that all suspected serious adverse reactions occurring within the Community to a veterinary medicinal product authorized in accordance with the provisions of this Regulation which are brought to his attention are recorded and reported immediately to the Member States in whose territory the incident occurred, and in no case later than 15 days following the receipt of the information.
Den for markedsføringen ansvarlige sikrer, at alle formodede alvorlige, uventede bivirkninger, som har manifesteret sig på et tredjelands omrade, indberettes til medlemsstaterne og agenturet straks eller i hvert fald senest 15 dage efter, at oplysningen er modtaget.
The aforementioned person shall ensure that all suspected serious unexpected adverse reactions occurring in the territory of a third country, are reported immediately to the Member States and the Agency and in no case later than 15 days following the receipt of the information.
Ordningerne for indberetning af formodede uventede bivirkninger, der ikke er alvorlige, uanset om de har manifesteret sig i Fællesskabet eller i et tredjeland, vedtages i overensstemmelse med artikel 48.
The arrangements for the reporting of suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, shall be adopted in accordance with Article 48.
Den for markedsføringen ansvarlige skid endvidere føre detaljerede fortegnelser over alle formodede bivirkninger, som har manifesteret sig i eller uden for Fællesskabet, og som indberettes til ham.
In addition, the person responsible for placing a veterinary medicinal product on the market shall be required to maintain detailed records of all suspected adverse reactions occurring within or outside the Community which are reported to him.
Medmindre der er fastsat andre krav som betingelse for Fællesskabets meddelelse af tilladelsen, forelægges disse fortegnelser agenturet og medlemsstaterne, så snart der anmodes derom eller mindst hver sjette måned i de første to år efter tilladelsen og en gang om året i de følgende tre år.
Unless other requirements have been laid down as a condition of the granting of the marketing authorization by the Community, these records shall be submitted to the Agency and Member States immediately upon request or at least every six months during the first two years following authorization and once a year for the following three years.
Hver medlemsstat sikrer, at alle formodede alvorlige bivirkninger, der på dens område har manifesteret sig ved et i henhold til denne forordning godkendt veterinærlægemiddel, og som den pågældende stat er gjort opmærksom på, registreres og indberettes til agenturet og den for markedsføringen ansvarlige straks eller i hvert fald senest 15 dage efter modtagelsen af oplysningen.
Each Member State shall ensure that all suspected serious adverse reactions occurring within their territory to a veterinary medicinal product authorized in accordance with the provisions of this Regulation which are brought to their attention are recorded and reported immediately to the Agency and the person responsible for placing the veterinary medicinal product on the market, and in no case later than 15 days following the receipt of the information.
Kommissionen skal i samrad med agenturet, medlemsstaterne og de berørte kredse udarbejde retningslinjer for indsamling, kontrol og udformning af bivirkningsfortegnelser.
The Commission in consultation with the Agency, Member States, and interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports.
Agenturet skal i samråd med medlemsstaterne og Kommissionen udarbejde et datanet med henblik på hurtig udveksling af data mellem alle kompetente myndigheder i Fællesskabet i tilfælde af varslinger om fabrikationsfejl, alvorlige bivirkninger og andre oplysninger i forbindelse med lægemiddelovervågningen af veterinærlægemidler, der markedsføres i Fællesskabet.
The Agency, in consultation with the Member States and the Commission, shall set up a data-processing network for the rapid transmission of data between the competent Community authorities in the event of an alert relating to faulty manufacture, serious adverse reactions and other pharmacovigilance data regarding veterinary medicinal products marketed in the Community.
Alle ændringer, som kan vise sig nødvendige for at ajourføre bestemmelserne i dette kapitel under hensyntagen til den videnskabelige og tekniske udvikling, skal vedtages efter fremgangsmåden i artikel 72.
Any amendment which may be necessary to update the provisions of this Chapter to take account of scientific and technical progress shall be adopted in accordance with the provisions of Article 72.
Agenturets opgave
Tasks of the Agency
Der oprettes et europæisk agentur for lægemiddelvurdering.
Article 49 A European Agency for the Evaluation of Medicinal Products is hereby established.
Agenturet har ansvaret for at koordinere de videnskabelige ressourcer, som medlemsstatemes kompetente myndigheder stiller til dets rådighed til vurdering og overvågning af lægemidler.
The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by the competent authorities of the Member States for the evaluation and supervision of medicinal products.
Udvalget for Veterinærlægemidler, som har ansvaret for at udarbejde agenturets udtalelser om spørgsmål vedrørende vurderingen af veterinærlægemidler c) et sekretariat, som yder de to udvalg teknisk og administrativ bistand og sørger for passende samordning af deres arbejde d) en eksekutivdirektør, som udfører de opgaver, der er fastsat i artikel 55 e) en styrelse, som udfører de opgaver, der er fastsat i artikel 56 og 57.
The Agency shall comprise: a) the Committee for Proprietary Medicinal Products, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use; b) the Committee for Veterinary Medicinal Products, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of veterinary medicinal products; c) a Secretariat, which shall provide technical and administrative support for the two Committees and ensure appropriate co-ordination between them; d) e) an Executive Director, who shall exercise the responsibilities set out in Article 55; a Management Board, which shall exercise the responsibilities set out in Articles 56 and 57.
Udvalget for Farmaceutiske Specialiteter og Udvalget for Veterinærlægemidler kan, hvis de finder det hensigtsmæssigt søge vejledning om vigtige spørgsmål af generel videnskabelig eller etisk art.
The Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.
For at fremme beskyttelsen af menneskers og dyrs sundhed og af lægemiddelforbrugeme i hele Fællesskabet og for at fremme gennemførelsen af det indre marked gennem vedtagelse af ensartede forskrifter baseret på videnskabelige kriterier for markedsføring og anvendelse af lægemidler har agenturet til opgave at yde medlemsstaterne og Fællesskabets institutioner den bedst mulige videnskabelige rådgivning om alle spørgsmål vedrørende vurdering af human- eller veterinærmedicinske lægemidlers kvalitet, sikkerhed og virkning, som det får forelagt i overensstemmelse med bestemmelserne i fællesskabsretten om lægemidler.
In order to promote die protection of human and animal health and of consumers of medicinal products throughout the Community, and in order to promote die completion of the internal market dirough die adoption of uniform regulatory decisions based on scientific criteria concerning the placing on die market and use of medicinal products, the objectives of the Agency shall be to provide the Member States and the institutions of die Community with the best possible scientific advice on any question relating to the evaluation of the quality, die safety, and the efficacy of medicinal products for human or veterinary use, which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.
Agenturet påtager sig navnlig følgende opgaver i sine udvalg: a) samordning af den videnskabelige vurdering af kvalitet, sikkerhed og virkning af lægemidler, som er omfattet af Fællesskabets markedsføringstilladelsesprocedurer b) forelæggelse af evalueringsrapporter, resuméer af produktegenskaber, etikettering af og indlægssedler for disse lægemidler c) samordning af overvågningen af den faktiske anvendelse af lægemidler, som er godkendt i Fællesskabet, og rådgivning om foranstaltninger til sikker og effektiv anvendelse af disse lægemidler, navnlig ved at vurdere oplysninger om de pågældende lægemidlers bivirkninger og gøre disse oplysninger tilgængelige gennem en database Gægemiddelovervågning) d) rådgivning om de maksimumsgrænser for restkoncentrationer af veterinærlægemidler, som i henhold til forordning (EØF) nr. 2377/90 kan accepteres i levnedsmidler af animalsk oprindelse e) samordning af kontrollen med overholdelsen af principperne for god fremstillingspraksis, god laboratoriepraksis og god klinisk praksis
To this end, the Agency shall undertake the following tasks within its Committees: a) the co-ordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to Community marketing authorization procedures; b) the transmission of assessment reports, summaries of product characteristics, labels and package leaflets or inserts for these medicinal products; c) the co-ordination of the supervision, under practical conditions of use, of medicinal products which have been authorized within the Community and the provision of advice on the measures necessary to ensure the safe and effective use of these products, in particular by evaluating and making available through a database information on adverse reactions to die medicinal products in question (pharmacovigilance); d) advising on the maximum limits for residues of veterinary medicinal products which may be accepted in foodstuffs of animal origin in accordance with Regulation (EEC) No 2377/90; e) coordinating the verification of compliance with the principles of good manufacturing practice, good laboratory practice and good clinical practice; f ) upon request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organizations and third countries on scientific and technical issues relating to the evaluation of medicinal products; g) recording die status of marketing authorizations for medicinal products granted in accordance with Community procedures: h) providing technical assistance for the maintenance of a database on medicinal products which is available for public use; i) assisting the Community and Member States in the provision of information to health care professionals and the general public about medicinal products which have been evaluated within the Agency; j) where necessary, advising companies on the conduct of the various tests and trials necessary to demonstrate the quality, safely and efficacy of medicinal products.
Udvalget for Farmaceutiske Specialiteter og Udvalget for Veterinærlægemidler består hver af to medlemmer udpeget af hver medlemsstat for en treårig periode, som kan fornyes.
The Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products shall each consist of two members nominated by each Member State for a term of 3 years which shall be renewable.
De udvælges på grundlag af deres rolle og erfaring med vurdering aflægemidler til mennesker eller dyr og repræsentanter deres kompetente myndigheder.
They shall be chosen by reason of their role and experience in the evaluation of medicinal products for human and veterinary use as appropriate and shall represent their competent authorities.
Eksekutivdirektøren eller dennes repræsentant samt repræsentanter for Kommissionen har ret til at overvære alle møder i udvalgene og i disses arbejdsgrupper og ekspertgrupper.
The Executive Director of the Agency or his representative and representatives of the Commission shall be entided to attend all meetings of the Committees, their working parties and expert groups.
I begge udvalgene kan medlemmerne lade sig ledsage af eksperter.
Members of each Committee may arrange to be accompanied by experts.
Ud over at give Fællesskabet og medlemsstaterne objektiv videnskabelig vejledning i spørgsmål, som de får forelagt, skal hvert udvalgs medlemmer sikre en passende samordning mellem agenturets opgaver og det arbejde, der udføres af nationale myndigheder, herunder af rådgivende organer, som beskæftiger sig med markedsføringstilladelser.
In addition to their task of providing objective scientific opinions to the Community and Member States on the questions which are referred to them, the members of each Committee shall ensure that there is appropriate co-ordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorization.
Udvalgsmedlemmerne og eksperterne med ansvar for vurdering af lægemidler skal anvende den sagkundskab og de videnskabelige ressourcer, som de nationale godkendelsesmyndigheder disponerer over.
The members of the Committees and the experts responsible for evaluating medicinal products shall rely on the scientific assessment and resources available to the national marketing authorization bodies.
Hver medlemsstat skal sikre, at vurderingen foretages pä et tilfredsstillende videnskabeligt grundlag, og skal føre tilsyn med den virksomhed der udføres af de udvalgsmedlemmer og eksperter, som den har udpeget, men afholde sig fra at give dem instrukser, som er uforenelige med deres opgaver.
Each Member State shall monitor the scientific level of the evaluation carried out and supervise the activities of members of the Committees and the experts it nominates, but shall refrain from giving them any instruction which is incompatible with the tasks incumbent upon them.
Hvis en sådan enighed ikke kan opnås, er flertallet af medlemmemes holdning afgørende for udtalelsen, som på de berørte medlemmers anmodning kan indeholde de afvigende holdninger og begrundelserne herfor.
If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and may, at the request of those concerned, include the divergent positions with their grounds.
Hvis Udvalget for Farmaceutiske Specialiteter eller Udvalget for Veterinærlægemidler i henhold til denne forordnings bestemmelser skal vurdere et lægemiddel, udpeger udvalget et af sine medlemmer til at optræde som rapportør i forbindelse med samordningen af vurderingen under hensyntagen til eventuelle forslag fra ansøgeren med hensyn til valget af rapportør.
Where, in accordance with the provisions of this Regulation, the Committee for Proprietary Medicinal Products or the Committee for Veterinary Medicinal Products is required to evaluate a medicinal product the Committee shall appoint one of its members to act as rapporteur for the co-ordination of the evaluation, taking into consideration any proposal from the applicant for the choice of a rapporteur.
Udvalget sørger for, at alle dets medlemmer optræder som rapportør eller medrapportør.
The Committee shall ensure that all its members undertake the role of rapporteur or co-rapporteur.
Medlemsstaterne sender agenturet en liste over eksperter med dokumenteret erfaring i evaluering af lægemidler, som står til rådighed for at deltage i arbejdsgrupper eller ekspertgrupper under Udvalget for Farmaceutiske Specialiteter eller Udvalget for Veterinærlægemidler, sammen med oplysninger om deres kvalifikationer og særlige sagkundskaber.
Member States shall transmit to the Agency a list of experts with proven experience in the assessment of medicinal products who would be available to serve on working parties or expert groups of the Committee for Proprietary Medicinal Products or the Committee for Veterinary Medicinal Products, together with an indication of their qualifications and specific areas of expertise.
Denne liste ajourføres efter behov.
This list shall be updated as necessary.
Efter forslag fra Udvalget for Farmaceutiske Specialiteter eller Udvalget for Veterinærlægemidler kan agenturet også benytte sig af rapportører eller eksperter til udøvelse af andre af agenturets særlige opgaver.
On a proposal from the Committee for Proprietary Medicinal Products or the Committee for Veterinary Medicinal Products, the Agency may also avail itself of the services of rapporteurs or experts for the discharge of other specific responsibilities of the Agency.
Navnene pä medlemmerne af Udvalget for Farmaceutiske Specialiteter og af Udvalget for Veterinærlægemidler offentliggøres.
The membership of the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products shall be made public.
Eksekutivdirektøren udpeges af styrelsen på forslag af Kommissionen for en femårig periode, som kan fornyes.
The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years, which shall be renewable.
Han er ansvarlig for. - den daglige administration af agenturet,
He shall be responsible: - for the day-to-day administration of the Agency,
- tilvejebringelse af passende teknisk støtte til Udvalget for Farmaceutiske Specialiteter og Udvalget for Veterinærlægemidler og disses arbejdsgrupper og ekspertgrupper,
- for the provision of appropriate technical support for the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, and their working parties and expert groups,
- overholdelse af de i fællesskabsretten fastsatte tidsfrister for agenturets afgivelse af udtalelser,
- for ensuring that the time limits laid down in Community legislation for the adoption of opinions by the Agency are respected,
- hensigtsmæssig samordning mellem Udvalget for Farmaceutiske Specialiteter og Udvalget for Veterinærlægemidler,
- for ensuring appropriate co-ordination between the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products,
- udirbejdel.se af oversigten over indtægter og udgifter og gennemførelse af agenturets budget,
- for the preparation of the statement of revenue and expenditure and the execution of the budget of the Agency, for all staff matters.