FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of medicines was once again in the spotlight in 2004, with two major classes of nationally authorised medicinal products causing serious public concern COX-2s and SSRIs both of which the EMEA conducted safety reviews of.
Danish: Sikkerheden ved lægemidler var atter i søgelyset i 2004, efter at to vigtige klasser af nationalt godkendte lægemidler gav anledning til alvorlig bekymring i offentligheden: COX-2 og SSRI.
English: 3.10 Improving the Agency's structures and procedures for veterinary medicines
Danish: 3.10 Forbedring af agenturets strukturer og procedurer for veterinærlægemidler
English: The EMEA, through its Committee for Medicinal Products for Human Use (CHMP), conducts a thorough scientific evaluation of all new applications for marketing authorisation concerning medicinal products for human use submitted through the Community or centralised procedure.
Danish: EMEA foretager via Udvalget for Humanmedicinske Lægemidler (CHMP) en grundig faglig vurdering af alle nye ansøgninger om markedsføringstilladelse for humanmedicinske lægemidler, der indgives efter EU-proceduren (den centraliserede procedure).
English: EU special contribution
Danish: Det særlige EU-tilskud
English: EGFRexpressing metastatic colorectal cancer in combination with irinotecan after failure of irinotecancontaining therapy
Danish: Treatment of patients with EGFRexpressing metastatic colorectal cancer in combination with irinotecan after failure of irinotecancontaining therapy
English: Wilson s disease
Danish: Treatment of Wilson's disease
English: • Judita HEDEROVÁ (Slovakia)
Danish: • Judita HEDEROVÁ (Slovakiet)
English: • Maria TOLLIS (Italy) Alternate: Virgilio DONINI
Danish: • Maria TOLLIS (Italien) suppleant: Virgilio DONINI
English: CVMP rapporteurs, co-rapporteurs and EMEA project managers reported (in the joint EMEA/IFAHEurope survey on the centralised procedure) a much greater level of satisfaction with the quality of dossiers submitted than was reported in the previous survey, in which the outcome had already been regarded as very positive.
Danish: CVMP-rapportører, medrapportører og EMEA-projektledere gav i den fælles redegørelse fra EMEA/IFAH-Europe om den centraliserede procedure udtryk for langt større tilfredshed med kvaliteten af det sagsmateriale, der indleveres.
English: Requests should be sent in writing to the EMEA or by e-mail to: europeanexperts@emea.eu.int
Danish: Skriftlig anmodning herom sendes til EMEA eller via e-mail til: europeanexperts@EMEA.eu.int
English: Almost half of the orphan medicinal products designated in 2004 are indicated for conditions that affect children.
Danish: Næsten halvdelen af de produkter, der i 2004 blev udpeget som lægemidler til sjældne sygdomme, er beregnet til behandling af lidelser hos børn.
English: The Agency also began, in July 2004, publishing the name of the active substance (international non-proprietary name, or INN), the orphan condition and the name of the sponsor for all designated orphan drugs submitted for marketing authorisation, in order to improve transparency with regard to orphan medicinal products.
Danish: Agenturet begyndte ligeledes i juli 2004 at offentliggøre betegnelsen på det aktive stof (det internationale fællesnavn eller INN), kriterierne og navnet på sponsoren i forbindelse med alle lægemidler til sjældne sygdomme, hvortil der søges markedsføringstilladelse, for at skabe øget åbenhed omkring lægemidler til sjældne sygdomme.
English: 3.3 Maximum residue limits
Danish: 3.3 Maksimale grænseværdier for restkoncentrationer
English: Studies and consultants
Danish: Undersøgelser og konsulenter Publikationer
English: • Beatriz SILVA LIMA (Portugal) Alternate: Cristina SAMPAIO
Danish: • Beatriz SILVA LIMA (Portugal) suppleant: Cristina SAMPAIO
English: Walter SCHWERDTFEGER (Alternate: Ilse-Dore SCHÜTT)
Danish: Walter SCHWERDTFEGER (suppleant: Ilse-Dore SCHÜTT)
English: The CHMP can request the involvement of the Pharmacovigilance Working Party and, in cases where specialised scientific input is needed, it can draw additional expertise from a pool of pharmacovigilance experts.
Danish: CHMP kan anmode om at få arbejdsgruppen vedrørende lægemiddelovervågning inddraget, og i de tilfælde, hvor der er behov for at høre eksperter med speciale i det pågældende område, kan udvalget desuden trække på en gruppe af udvalgte eksperter.
English: • Bruno URBAIN (Belgium) Alternate: Lionel LAURIER
Danish: • Bruno URBAIN (Belgien) suppleant: Lionel LAURIER
English: The fund supports new marketing authorisation applications for orphan medicinal products, as well as protocol assistance and post-authorisation activities relating to these medicines.
Danish: Fonden støtter nye ansøgninger for lægemidler til sjældne sygdomme samt protokolbistand og aktiviteter efter godkendelse i forbindelse med de pågældende lægemidler.
English: Sterile medicinal products and some biological medicinal products are excluded from the scope.
Danish: Sterile lægemidler og visse biologiske lægemidler er ikke omfattet af aftalen, som desuden kun dækker humanmedicinske lægemidler.
English: EMEA and WHO representatives participated in each other s meetings to discuss matters of global significance, such as tropical diseases, influenza pandemics, pharmacovigilance and consultations on international non-proprietary names (INNs).
Danish: Repræsentanter for EMEA og WHO deltog i møderne i begge organisationer for at drøfte spørgsmål af global betydning, bl.a. tropiske sygdomme, influenzapandemier, lægemiddelovervågning og samråd om internationale fællesnavne (INN).
English: Experts
Danish: Eksperter
English: • Liisa KAARTINEN (Finland) Alternate: Kristina LEHMANN
Danish: • Liisa KAARTINEN (Finland) suppleant: Kristina LEHMANN
English: Members
Danish: Medlemmer
English: Good laboratory practice (GLP) activities
Danish: God laboratoriepraksis (GLP)
English: 3.11 Veterinary mutual recognition facilitation group
Danish: 3.11 Den veterinærmedicinske gruppe for fremme af gensidig anerkendelse
English: This was one of the key components helping the Sector achieve availability targets of 99.5 %
Danish: Det var en afgørende forudsætning for, at IT-sektionen kunne opnå en rådighedsgrad på 99,5 %
English: The EMEA/MRFG secretariat can be contacted by e-mail to: mrp@emea.eu.int
Danish: EMEA/MRFG-sekretariatet kan kontaktes via e-mail til: mrp@EMEA.eu.int
English: This indicates that there were fewer premature applications.
Danish: Det tyder på, at der kun indkom få ansøgninger, som ikke var tilstrækkeligt forberedt.
English: The EMEA offers to hold pre-submission meetings with sponsors who intend to submit an application for orphan designation.
Danish: EMEA tilbyder at afholde forudgående møder med sponsorer, der har til hensigt at indgive ansøgning om udpegelse af et produkt som lægemiddel til sjældne sygdomme.
English: A new data centre was constructed in 2004 with storage mirroring capability and critical redundant services deployed, combined with the implementation of a new LAN with sophisticated data switching equipment at the EMEA.
Danish: Der blev i 2004 indrettet et nyt datacenter i EMEA med "Storage Mirroring"-funktion og kritiske redundante tjenester kombineret med installering af et nyt LAN med avanceret dataomdirigeringsudstyr.
English: In addition, the EMEA was pleased to support the launch of the IFAH-Europe Good Veterinary Pharmacovigilance Practice Guide, produced by Industry to encourage further advances in the consistent reporting of ADRs throughout the Community.
Danish: EMEA var også meget tilfreds med at kunne støtte udgivelsen af IFAH-Europe's vejledning i god praksis for overvågning af veterinærlægemidler, som er udarbejdet af industrien selv for at tilskynde til større ensartethed i indberetningerne af bivirkninger overalt i EU.
English: Respiratory system
Danish: Respiratoriske system
English: Head of Sector for veterinary marketing authorisation procedures Jill ASHLEY-SMITH Deputy Head of Sector for veterinary marketing authorisation procedures
Danish: Sektionsleder - markedsføringstilladelser for veterinærlægemidler Jill ASHLEY-SMITH Vicesektionsleder - markedsføringstilladelser for veterinærlægemidler
English: The development and revision of scientific guidelines is a particularly important aspect of the work of the working parties as they contain guidance on specific scientific issues and are based on the most upto-date scientific knowledge available, providing essential information to be taken into account in the research and development of new medicines.
Danish: Udarbejdelse og revision af videnskabelige retningslinjer er et særlig vigtigt aspekt af arbejdsgruppernes opgaver, fordi de kan vejlede om specifikke videnskabelige spørgsmål og er baseret på den nyeste videnskabelige ekspertise, der er til rådighed, og indeholder væsentlige oplysninger af betydning for forsknings- og udviklingsarbejdet med nye lægemidler.
English: Marketing authorisation holders are required to submit a PSUR at regular intervals or upon request.
Danish: Indehavere af markedsføringstilladelser er forpligtet til at foretage sådanne indberetninger med faste intervaller eller på anmodning.
English: See Annex 8 for key internal IT projects and operational activities undertaken and delivered.
Danish: Bilag 8 indeholder en oversigt over de vigtigste interne IT-projekter og operationelle aktiviteter, der blev gennemført i årets løb.
English: In addition, a new Scientific Advice Working Party was created, and its mandate and work objectives agreed by the CVMP.
Danish: Der blev desuden nedsat en ny arbejdsgruppe vedrørende videnskabelig rådgivning, og CVMP godkendte gruppens mandat og arbejdsmålsætninger.
English: Many of these projects were big and involved development and deployment through collaboration with the EMEA Human and Veterinary Units.
Danish: Mange af disse projekter var ganske omfattende og indebar samarbejde med EMEA's afdelinger for henholdsvis humanmedicinske og veterinærmedicinske lægemidler.
English: 18 of the 21 members are appointed by the CHMP and 3 members are appointed by the COMP.
Danish: Desuden blev den nye arbejdsgruppe udvidet fra 18 til 21 medlemmer, hvoraf de 18 udpeges af CHMP og 3 af COMP.
English: • The Scientific Advisory Group on Antimicrobials was created as planned, and its mandate and work objectives agreed and formalised by the CVMP.
Danish: • Der blev som planlagt nedsat en videnskabelig rådgivende gruppe for antimikrobielle stoffer, og CVMP gav sin formelle godkendelse af gruppens mandat og arbejdsmålsætninger.
English: • Heribert PITTNER (Austria)
Danish: • Heribert PITTNER (Østrig)
English: Revision 2 finalised in July 2004
Danish: Revision 2 afsluttet i juli 2004
English: These certify the marketing authorisation and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
Danish: Certifikaterne attesterer, at der er udstedt markedsføringstilladelse, og at reglerne for god fremstillingspraksis for lægemidler i EU er overholdt, og skal efter hensigten vedlægges ansøgninger om markedsføringstilladelse i og ved eksport til lande uden for EU.
English: A standard operating procedure for coordination of PMF inspections and a guideline on PMF/VAMF 2nd step were developed and published in 2004.
Danish: Der blev i 2004 udarbejdet og offentliggjort en standardprocedure for koordineringen af PMF-inspektioner og en vejledning om "andet trin" i behandlingen af PMF/VAMF.
English: After a one-year period of implementation, changes have been introduced to the pilot procedure for follow-up of test results to streamline the reporting structures.
Danish: Efter at pilotproceduren for opfølgning på testresultater havde fungeret et år, blev der foretaget visse ændringer for at gøre indberetningsstrukturerne mere ensartede.
English: • Ian HUDSON (United Kingdom) Alternate: Julia DUNNE
Danish: • Ian HUDSON (Det Forenede Kongerige) suppleant: Julia DUNNE
English: In previous years, discharge was given by the Agency s Management Board.
Danish: Tidligere var det bestyrelsen, der meddelte decharge for budgettet.
English: • Change to the composition of the Management Board, CHMP and CVMP
Danish: • ændring af bestyrelsens sammensætning og sammensætningen af CHMP og CVMP
English: The Management Board adopted new rules on access to EMEA documents at its March 2004 meeting.
Danish: Bestyrelsen vedtog på sit møde i marts 2004 nye regler om adgangen til EMEA-dokumenter.
English: • Raul KIIVET (Estonia) Alternate: Alar IRS
Danish: • Raul KIIVET (Estland) suppleant: Alar IRS
English: Post-authorisation applications
Danish: Ansøgninger efter godkendelse
English: The code ensures that a consistent standard of professional conduct applies to all parties associated with the EMEA s work and responsibilities.
Danish: Disse etiske regler sikrer, at der gælder ensartede krav til faglig adfærd for alle, der er inddraget i EMEA's arbejde og ansvarsområder.
English: • Jolanta WIECKOWSKA (Poland)
Danish: • Jolanta WIECKOWSKA (Polen)
English: 6.4 Document management and publishing
Danish: 6.4 Styring og offentliggørelse af dokumenter
English: Ľudevít MARTINEC (Alternate: Stanislava GAJDO OVÁ)
Danish: Ľudevít MARTINEC (suppleant: Stanislava GAJDOŠOVÁ)
English: • Rory BREATHNACH (Irland) (co-opted)
Danish: • Rory BREATHNACH (Irland) (indvalgt)
English: Date of decision
Danish: Dato for afgørelse
English: Cardiovascular system
Danish: Kardiovaskulære system
English: Regulatory and procedural guidance or advice is provided to the pharmaceutical industry during the lifecycle of medicinal products, starting from pre-submission meetings with applicants through to annual meetings with marketing authorisation holders (MAHs).
Danish: Lægemiddelindustrien modtager vejledning eller rådgivning om love, regler og procedurer igennem lægemidlernes fulde livscyklus, begyndende med møder med ansøgere forud for indgivelsen af selve ansøgningen og videre med årlige møder med indehaverne af markedsføringstilladelser.
English: The provision of scientific advice is a priority area for the EMEA as it benefits companies developing new medicinal products and thus contributes to the availability of innovative medicines for EU citizens.
Danish: EMEA prioriterer opgaven med at yde videnskabelig rådgivning meget højt, fordi den er til fordel for virksomheder, der arbejder med at udvikle nye lægemidler, og dermed bidrager til at stille innovative lægemidler til rådighed for EU's borgere.
English: • The CHMP recommended approval of an anti-cancer drug that targets folate-dependent reactions that are essential for cell proliferation.
Danish: • CHMP anbefalede godkendelse af et middel til behandling af cancer, rettet mod folatafhængige reaktioner, der er afgørende for celleformeringen.
English: • Conception, elaboration and early construction phases of a scientific advice database were completed in 2004
Danish: • I 2004 blev man færdig med udarbejdelsen og den indledende opbygning af en database over videnskabelig rådgivning.
English: • Michał PIROŻYŃSKI (Poland) Alternate: Piotr SIEDLECKI
Danish: • Michał PIROŻYŃSKI (Polen) suppleant: Piotr SIEDLECKI
English: Dairíne DEMPSEY (Ireland) Alternate: Elaine BRESLIN
Danish: Dairíne DEMPSEY (Irland) suppleant: Elaine BRESLIN
English: The work of the CVMP is supported by a number of working parties, composed of European experts selected from a list maintained by the EMEA.
Danish: CVMP bistås i sit arbejde af et antal arbejdsgrupper bestående af europæiske eksperter, der er valgt fra en liste, EMEA fører.
English: • The contract for building the Product Information Management (PIM) system was placed following completion of a specification exercise
Danish: • Efter at specificeringsfasen var afsluttet, blev der indgået kontrakt om opbygning af produktinformationsstyringssystemet (PIM)
English: This is an increase of 5 over the previous year, and reflects the continuing emergence of new active substances for food-producing animals.
Danish: Det er fem flere end året før og kan tilskrives, at det hele tiden lanceres nye aktive stoffer til brug for dyr, hvis produkter anvendes til menneskeføde.
English: 2004 saw the first cooperation with the European Food Safety Authority (EFSA), involving the establishment of maximum residue limits for Lasalocid sodium (coccidiostat) for chicken and game birds, which was also evaluated in 2004 by EFSA for approval as a feed additive.
Danish: I 2004 indledtes samarbejdet med Den Europæiske Fødevaresikkerhedsautoritet (EFSA) om bl.a. fastsættelse af maksimale grænseværdier for Lasalocid sodium (coccidiostat) i kyllinger og vildtfugle.
English: Product INN Sponsor
Danish: Lægemidlets INN Sponsor
English: Vytautas BASYS (Alternate: Juozas JOKIMAS)
Danish: Vytautas BASYS (suppleant: Juozas JOKIMAS)
English: • Patricia VELLA BONANNO9 (Malta) Alternate: John Joseph BORG10
Danish: • Patricia VELLA BONANNO9 (Malta) suppleant: John Joseph BORG10
English: • Katarzyna KRZYŻAŃSKA (Poland) Alternate: Roman LECHOWKSI
Danish: • Katarzyna KRZYŻAŃSKA (Polen) suppleant: Roman LECHOWKSI
English: • Eva JOHNSSON (Sweden) Alternate: Henrik HOLST
Danish: • Eva JOHNSSON (Sverige) suppleant: Henrik HOLST
English: EMEA/COMP !
Danish: EMEA/COMP Ansøg.
English: In the case of sponsors developing designated orphan medicinal products, the scientific advice provided by the Agency is referred to as protocol assistance and is offered free of charge.
Danish: Hvor det drejer sig om sponsorer, der udvikler lægemidler til sjældne sygdomme, betegnes agenturets rådgivning som protokolbistand og ydes vederlagsfrit.
English: Oncology and immunology
Danish: Onkologi og immunologi
English: 2.2 Scientific advice and protocol assistance
Danish: 2.2 Videnskabelig rådgivning og protokolbistand
English: Arbitration and Community referrals received/forecast (Input)
Danish: Modtagne/forventede voldgiftssager og EU-henvisningssager (input)
English: Validation Assessment
Danish: Validering Vurdering
English: • Tonje HØY (Norway) Alternate: Hanne BERGENDAHL
Danish: • Tonje Høy (Norge) suppleant: Hanne Bergendahl
English: Catherine HARVALA (Greece) Alternate: Foteini TZAVELLA
Danish: Catherine HARVALA (Grækenland) suppleant: Foteini TZAVELLA
English: Specifications: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: Chemical substances
Danish: VICH Topic GL39Specifications: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: Chemical substances
English: Members of the Management Board
Danish: Medlemmer af bestyrelsen
English: • Johannes DICHTL (Austria) Alternate: Jean-Pierre BINDER
Danish: • Johannes DICHTL (Østrig) suppleant: Jean-Pierre BINDER
English: PSURs, specific obligations and follow-up measures
Danish: PSUR, særlige forpligtelser (SO) og opfølgningsforanstaltninger (FUM)
English: Clinical trials databases
Danish: Databaser om kliniske forsøg
English: 8 Replaced Pekka KURKI as of September 2004 meeting.
Danish: 8 Trådte i stedet for Pekka KURKI fra sept. 2004.
English: It remains challenging to accurately predict the number of applications to be received, despite forecasts supplied by Industry, as there is, unfortunately, little intelligence available in the veterinary sector regarding new products in the development pipeline.
Danish: Det er fortsat vanskeligt præcist at forudsige antallet af ansøgninger på trods af prognoser fra lægemiddelindustrien, fordi der i
English: • Eric ABADIE (France) (vice-chairman) Alternate: Jean-Hugues TROUVIN
Danish: • Eric ABADIE (Frankrig) (næstformand) suppleant: Jean-Hugues TROUVIN
English: • Giuseppe NISTICÒ (Italy) Alternate: Pasqualino ROSSI
Danish: Giuseppe NISTICÒ (Italien) suppleant: Pasqualino ROSSI
English: To ensure that the help and support available to EMEA staff, delegates and users of EU telematics systems is in line with the Agency s operating requirements
Danish: Hjælp og support til EMEA's ansatte, delegerede og brugere af EUtelematiksystemer skal være i overensstemmelse med agenturets driftsmæssige behov
English: The objective of the guide is to inform veterinarians and other animal-health professionals about the pharmacovigilance system for veterinary medicinal products in the EU and to stimulate their cooperation on the reporting of adverse drug reactions (ADRs).
Danish: Formålet med vejledningen er at informere dyrlæger og andre fagfolk i veterinærsektoren om EU's overvågningssystem for veterinærlægemidler og opfordre dem til at samarbejde omkring indberetning af bivirkninger.
English: • Bernd JILMA (Austria)
Danish: • Bernd JILMA (Østrig)
English: • Kateřina KUBÁČKOVÁ (Czech Republic)
Danish: • Kateřina KUBÁČKOVÁ (Tjekkiet)
English: New applications (by medicinal product) New applications (by active substance) Orphan medicinal products (included in total applications)
Danish: Nye ansøgninger (opgjort efter lægemiddel) Nye ansøgninger (opgjort efter aktivt stof) Lægemidler til sjældne sygd.
English: This has radically improved the EMEA s ability to arrange all meetings and conferences
Danish: Det har gjort det væsentligt lettere for EMEA at arrangere møder og konferencer.
English: • Gottfried KREUTZ (Germany) Alternate: Karl BROICH2
Danish: • Gottfried KREUTZ (Tyskland) suppleant: Karl BROICH2
English: 3 Veterinary medicines
Danish: 3 Veterinærlægemidler
English: • Safety Working Party
Danish: • Arbejdsgruppen vedrørende sikkerhed
English: • Eduardo MARQUES-FONTES (Portugal) Alternate: Leonor Maria MEISEL
Danish: • Eduardo MARQUES-FONTES (Portugal) suppleant: Leonor Maria MEISEL
English: • Sigurður ÖRN HANSSON (Iceland) Alternate: Halldór RUNÓLFSSON
Danish: • Sigurður ÖRN HANSSON (Island) suppleant: Halldór RUNÓLFSSON
English: Five of the applications were for companion animals and 3 for food-producing animals, namely horses.
Danish: Fem af ansøgningerne tog sigte på kæledyr, og tre vedrørte dyr, hvis produkter anvendes til menneskeføde, i alle tre tilfælde heste.
English: Gro Ramsten WESENBERG (Alternate: Hans HALSE)
Danish: Gro Ramsten WESENBERG (suppleant: Hans HALSE)
English: • Peter EKSTRÖM (Sweden) (co-opted)
Danish: • Peter EKSTRÖM (Sverige) (indvalgt)
English: • Jean-Claude ROUBY (France) Alternate: Michael HOLZHAUSERALBERTI
Danish: • Jean-Claude ROUBY (Frankrig) suppleant: Michael HOLZHAUSERALBERTI
English: The Committee adopted its key position paper in June 2004 setting out to further define the problem and offering solutions to try and resolve matters from a regulatory perspective.
Danish: Udvalget vedtog i juni 2004 et holdningsdokument med en grundig redegørelse for problemstillingen og forslag til løsninger baseret på lovgivning.
English: The Management Board met 5 times in 2004:
Danish: Der blev afholdt fem bestyrelsesmøder i 2004:
English: Specifications: Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
Danish: VICH Topic GL40Specifications: Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
English: Patricia VELLA BONANNO (Alternate: Kenneth MIFSUD)
Danish: Patricia VELLA BONANNO (suppleant: Kenneth MIFSUD)
English: • Kristina PAVLOVSKA (Latvia)
Danish: • Kristina PAVLOVSKA (Letland)
English: • Reinhard KROKER (Germany) Alternate: Manfred MOOS
Danish: • Reinhard KROKER (Tyskland) suppleant: Manfred MOOS
English: In addition, regulatory and procedural guidance is provided to the CHMP, HMPC and COMP, and to their related working parties and ad hoc groups.
Danish: Desuden modtager CHMP, HMPC og COMP og de dertil knyttede arbejdsgrupper og ad hoc-grupper vejledning i love, regler og procedurer.
English: Useful website: EudraVigilance http://eudravigilance.emea.eu.int
Danish: Nyttigt websted: EudraVigilance http://eudravigilance.EMEA.eu.int
English: • Birgit AASMÄE (Estonia) Alternate: Helen MAHLA
Danish: • Birgit AASMÄE (Estland) suppleant: Helen MAHLA
English: EMEA budget evolution in euro
Danish: Udviklingen i EMEA's budget