natgillin/translations-raw huggingface dataset:
Metaanalysen fra CTU fik massiv medieomtale tidligere på året, hvor hovedvinklen var, at antidepressiv medicin er uden effekt. 
The CTU’s meta-analysis attracted considerable media coverage earlier this year, the key focus of which was that antidepressants have no effect.
Undersøgelsen fra Copenhagen Trial Unit sammenligner forsøgsgrupper i forskellige undersøgelser på en måde, som efter Lægemiddelstyrelsens vurdering ikke er videnskabeligt holdbar. 
The CTU’s review compares groups of trial subjects in different trials in a way that is not scientifically valid, in the opinion of the Danish Medicines Agency.
Valuta 
The currency
Den kommende og den nuværende tilskudsstatus ses i tabellen nedenfor. 
The current and future reimbursement status can be seen in the below table.
De gældende og væsentligste bekendtgørelser der inspiceres efter er: 
The current and most important executive orders forming the basis for inspections are:
Det nuværende prisniveau kan sammenlignes med det prisniveau, der var gældende i denne periode. 
The current price level is comparable to the price level applying for this period.
Gældende udgaver af European Medicines Agency Good Pharmacovigilance Practices 
The current version of the European Medicines Agency's Good Pharmacovigilance Practices
Dette forhold er der taget højde for i den nu foreslåede tilskudsklausul for angiotensin-II antagonisterne. 
The currently suggested reimbursement condition for angiotensin II antagonists takes this actuality into account.
Disse CVMP-anbefalinger gælder ikke cabergolin til hobbydyr eller mennesker. 
The CVMP recommendations do not include cabergoline for pets or humans.
CVMPs afgørelse er formelt en indstilling til EU-kommissionen, der træffer den endelige afgørelse. 
The CVMP’s conclusion is a recommendation to the European Commission that will make the final decision.
CVMP’s beslutning i EMA’s pressemeddelelse fra CVMP mødet 
The CVMP’s decision in the EMA’s press release about the CVMP meeting
Lov om medicinsk udstyr danner den lovmæssige ramme om medicovirksomheders og forretningers indberetnings- og informationspligt, når de knytter sundhedspersoner til virksomheden. 
The Danish Act on Medical Devices provides the legal framework for medical device companies’ and stores’ reporting obligation and duty to inform when they establish a relationship with a healthcare professional.
E-læringen henvender sig til både virksomhedsejere, butikschefer og medarbejdere, der skal til eller som allerede er i gang med at forhandle håndkøbslægemidler. 
The Danish advertising rules are complied with, see The Danish Medicines Act and the Danish executive order on advertising for medicinal products (in Danish).
Landbrugsstyrelsen ingen indvendinger har til de langbrugsfaglige forhold. 
The Danish Agricultural Agency does not object to the agricultural conditions.
Der er mange sproglige forhold, som er forskellige fra dansk til engelsk. 
The Danish and English languages have many differences from a linguistic point of view.
Lægemiddelindustriforeningen (Lif), Industriforeningen for Generiske Lægemidler (IGL), Parallelimportørforeningen af Lægemidler (Pfl) og Amgros er gået sammen om at finde en løsning med stregkoder på inder- og yderpakning. 
The Danish Association of the Pharmaceutical Industry (Lif), the Danish Generic Medicines Industry Association (IGL), the Danish Association of Parallel Importers of Medicine and Amgros have joined forces to find a solution involving barcodes on inner and outer packaging.
Lif skriver, at hver patient bør konsultere lægen to gange for at få tilpasset den ændrede behandling, hvilket indebærer et skjult ressourceforbrug for både de praktiserende læger og patienterne. 
The Danish Association of the Pharmaceutical Industry states that each patient should contact his or her general practitioner twice to have his or her changed treatment adapted, which involves a hidden resource consumption for both the general practitioner and the patient.
Kræftens Bekæmpelse vurderer, at det danske vaccinationsprogram allerede har forebygget mindst 1.400 tilfælde af livmoderhalskræft og reddet ca. 280 liv. 
The Danish Cancer Society estimates that the Danish vaccination programme has prevented at least 1,400 cervical cancer cases and saved around 280 lives.
I børnevaccinationsprogrammet vaccineres mod følgende sygdomme: Difteri, stivkrampe, kighoste, polio (børnelammelse), hjernehinde-og strubelågsbetændelse forårsaget af bakterien Haemophilus influenzae type b (Hib-bakterien), hjernehindebetændelse og andre alvorlige sygdomme forårsaget af pneumokokbakterien, mæslinger, fåresyge, røde hunde og livmoderhalskræft (piger). 
The Danish childhood immunisation programme includes vaccination against the following diseases: Diphtheria, tetanus, pertussis, polio (infantile paralysis), meningitis and epiglottitis caused by Haemophilus influenzae type b (Hib), meningitis and other serious diseases caused by pneumococci, measles, mumps, rubella and cervical cancer (girls).
Det danske børnevaccinationsprogram er et tilbud til alle børn om gratis vaccination mod ni infektionssygdomme. 
The Danish childhood immunisation programme is offered free of charge to all children and includes vaccination against nine infectious diseases.
Komitéloven ændres ligeledes med hensyn til sponsors, monitors og investigators adgang til at indhente de nødvendige helbredsoplysninger. 
The Danish Committee Act has also been amended as regards the sponsor's, monitor's and investigator's access to obtain the required health information.
Virksomhedsnummeret er et unikt administrativt nummer, som Lægemiddelstyrelsen har tilknyttet den enkelte virksomhed. 
The Danish company number is a unique administrative number which Danish Health and Medicines Authority has given each individual company.
Den danske delegation bestod af professor Steen Honoré Hansen fra Farmaceutisk Fakultet og Erik Wolthers fra Lægemiddelstyrelsen. 
The Danish delegation consisted of Professor Steen Honoré Hansen from the Faculty of Pharmaceutical Sciences of the University of Copenhagen and Erik Wolthers from the Danish Medicines Agency.
Den danske delegation bestod af professor Steen Honoré Hansen fra Farmaceutisk Fakultet samt Erik Wolthers fra Lægemiddelstyrelsen. 
The Danish delegation consisted of Professor Steen Honoré Hansen from the Faculty of Pharmaceutical Sciences of the University of Copenhagen and Erik Wolthers from the Danish Medicines Agency.
Den danske delegation bestod af professor Steen Honoré Hansen fra Farmaceutisk Fakultet samt Eva Sandberg og Erik Wolthers fra Lægemiddelstyrelsen. 
The Danish delegation consisted of Professor Steen Honoré Hansen from the Faculty of Pharmaceutical Sciences of the University of Copenhagen as well as Eva Sandberg and Erik Wolthers from the Danish Medicines Agency.
Den danske delegation bestod af professor Steen Honoré Hansen fra Farmaceutisk Fakultet samt Eva Sandberg og Erik Wolthers, begge fra Lægemiddelstyrelsen. 
The Danish delegation consisted of Professor Steen Honoré Hansen from the Faculty of Pharmaceutical Sciences of the University of Copenhagen as well as Eva Sandberg and Erik Wolthers from the Danish Medicines Agency.
I Danske Lægemiddelstandarder samt Den Europæiske Farmakopé (Ph. Eur.) er defineret forskellige lægemiddelformer samt tekniske krav hertil. 
The Danish Drug Standards and the European Pharmacopoeia (Ph. Eur.) define various pharmaceutical forms and the related technical requirements.
Den Danske Ambassade i Beijing har været af uvurderlig nytte undervejs. 
The Danish Embassy in Beijing has been extremely helpful in this process.
Dansk Endokrinologisk Selskab, Dansk Gastroenterologisk Selskab, Dansk Gerontologisk Selskab, Dansk Kirurgisk Selskab, Dansk Medicinsk selskab, Dansk Pædiatrisk Selskab, Dansk selskab for Almen Medicin, Dansk Selskab for Geriatri, Dansk Selskab for Hepatologi, Dansk Selskab for Intern Medicin, Dansk Selskab for Klinisk Ernæring, Dansk selskab for Klinisk Farmakologi og Dansk Selskab for Klinisk Onkologi. 
the Danish Endocrine Society, Danish Society for Gastroenterology, Danish Gerontological Society, Danish Surgical Society, Danish Medical Society, Danish Paediatric Society, Danish College of General Practitioners, Danish Society of Geriatrics, Danish Association for the Study of the Liver, Danish Society of Internal Medicine, Danish Society for Clinical Nutrition and Metabolism, Danish Society of Clinical Pharmacology and Danish Society of Clinical Oncology.
I GCP-bekendtgørelsen er der anført en minimumsliste over dokumenter, der genereres før, under og efter forsøget, og som skal opbevares i Trial Master File hos henholdsvis sponsor og investigator. 
The Danish executive order on GCP contains a minimum list of documents generated before, during and after the trial, which must be stored in the Trial Master File with the sponsor and investigator, respectively.
Bekendtgørelsen om mineral- og vitaminpræparater omhandler kun produkter til mennesker og ikke til dyr. 
The Danish Executive Order on vitamin and mineral products only covers products for human and not for veterinary consumption.
Af bekendtgørelsen om vitamin- og mineralpræparater fremgår det, at præparaterne "skal være fremstillet i en virksomhed, der råder over den fornødne faglige kundskab, og hvis indretning og drift anses at sikre en betryggende fremstilling af lægemidler." 
The Danish Executive Order on vitamin and mineral products states that the products “must be manufactured in a company which possesses the required professional knowledge, and the design and operation of which is considered to ensure safe manufacturing of medicinal products”.
GCP-bekendtgørelsen og ICH GCP-guideline definerer, hvilke dokumenter, der skal foreligge i et forsøgs Trial Master File. 
The Danish GCP executive order and the ICH GCP guidelines define the documents that must be available in the Trial Master File for a clinical trial.
Regeringen, Dansk Folkeparti og Radikale Venstre er enige om at fritage kommercielle sponsorer for alle gebyrer for fase I-forsøg med lægemidler. 
The Danish government, the Danish People's Party and the Danish Social-Liberal Party have agreed to exempt commercial sponsors from all fees for phase I clinical trials of medicines.
Regeringens pressemeddelelse om det danske EMA kandidatur 
The Danish Government’s press release about Denmark’s candidacy for hosting the EMA
Sundhedslovens kapitel 61 a: Industrisamarbejde og lov om medicinsk udstyr danner den lovmæssige ramme om økonomisk støtte fra medicovirksomheder. 
The Danish Health Act, Part 61 a: Industrial collaboration and the Danish act on medical devices provide the legal framework for financial support from medical device companies.
Sundhedslovens kapitel 61 a: Industrisamarbejde og lægemiddelloven danner den lovmæssige ramme om økonomisk støtte fra lægemiddelvirksomheder. 
The Danish Health Act, Part 61 a: Industrial collaboration and the Danish Medicines Act provide the legal framework for financial support from pharmaceutical companies.
Sundhedslovens kapitel 61 a: Industrisamarbejde danner den lovmæssige ramme om tandlægers tilknytning til lægemiddel-og medicovirksomheder. 
The Danish Health Act, Part 61 a: Industrial collaboration provides the legal framework for dentists’ relationships with pharmaceutical and medical device companies.
Sundhedslovens kapitel 61 a: Industrisamarbejde danner den lovmæssige ramme om lægers tilknytning til lægemiddel-og medicovirksomheder og specialforretninger med medicinsk udstyr. 
The Danish Health Act, Part 61 a: Industrial collaboration provides the legal framework for doctors’ relationships with pharmaceutical and medical device companies and stores specialised in the sale of medical devices.
Sundhedslovens kapitel 61 a: Industrisamarbejde danner den lovmæssige ramme om sygeplejerskers tilknytning til medicovirksomheder. 
The Danish Health Act, Part 61 a: Industrial collaboration provides the legal framework for nurses’ relationships with medical device companies.
Sundhedsstyrelsen er projektleder for etableringen af en fælles ansøgningsportal for det videnskabsetiske system og Sundhedsstyrelsen. 
The Danish Health and Medicines Authority acts as project manager for the development of a common application portal for the ethics committee system and the Danish Health and Medicines Authority.
Både i Sundhedsstyrelsen og i resten af EU er der øget opmærksomhed på anvendelse af medicin til behandlinger, der ikke er omfattet af medicinens godkendte produktresumé, og på behovet for udvikling af bedre overvågning af sikkerheden i forbindelse med off label-brug af medicin. 
The Danish Health and Medicines Authority and the EU have increased attention on the use of medicines for treatments that are not covered by the medicine's authorised summary of product characteristics and on the need for the development of improved monitoring of safety in connection with off-label use of medicines.
Sundhedsstyrelsen er i samarbejde med de europæiske lægemiddelmyndigheder i gang med en vurdering af sikkerheden ved brug af paracetamol under graviditet, og resultaterne fra det nye danske studie vil blive inddraget i analysen sammen med den øvrige viden på området. 
The Danish Health and Medicines Authority and the European drug regulatory authorities are currently assessing the safety of paracetamol use during pregnancy, and the results of the new Danish study will form part of the analysis together with the other knowledge in the area.
Sundhedsstyrelsen har i samarbejde med Patientombuddet sat gang i en analyse af indberettede bivirkninger og utilsigtede hændelser med lægemidler til igangsætning af fødsler. 
The Danish Health and Medicines Authority and the National Agency for Patients' Rights and Complaints have started an analysis of reported side effects and adverse events involving medicines for labour induction.
Sundhedsstyrelsen og videnskabsetisk komité skal give tilladelse til gennemførelse af et klinisk forsøg med medicin på mennesker. 
The Danish Health and Medicines Authority and the research ethics committee must give authorisation to the conduct of clinical trials of medicinal products in humans.
Du skal underrette Sundhedsstyrelsen og Komitésystemet, hvis der opstår ny viden, der har betydning for forsøgspersonernes sikkerhed, mens forsøget gennemføres. 
The Danish Health and Medicines Authority and the Scientific Ethical Committee System must be informed if new knowledge of importance to the safety of trial subjects emerges while the trial is conducted.
Sundhedsstyrelsen vurderer, at fordelene ved vaccinerne fortsat opvejer de mulige risici. 
The Danish Health and Medicines Authority assesses that the benefits of the vaccines still outweigh the possible risks.
Styrelsen kan forbyde forhandling og udlevering af et lægemiddel og påbyde, at det trækkes tilbage fra markedet, hvis virksomheden ikke er i besiddelse af en gældende § 39-tilladelse. 
The Danish Health and Medicines Authority can prohibit any distribution and dispensing of a medicinal product and order that a product be withdrawn from the market if the company does not hold a valid section 39 authorisation.
På baggrund af data i studiet vurderer Sundhedsstyrelsen, at der ikke på nuværende tidspunkt er anledning til at ændre anbefalingerne for brug af smertestillende medicin under graviditeten. 
The Danish Health and Medicines Authority does not find that the research data call for an immediate change of the recommendations for use of painkillers during pregnancy.
Lægemiddelstyrelsen har ingen planer om at udarbejde en dansk version. 
The Danish Health and Medicines Authority does not plan to prepare a Danish version.
Sundhedsstyrelsen opfordrer til at anvende denne mulighed. 
The Danish Health and Medicines Authority encourages applicants to make use of this opportunity.
Sundhedsstyrelsen forventer, at der bliver inkluderet 16.882 danske forsøgspersoner i de 294 forsøg som er ansøgt i 2013. 
The Danish Health and Medicines Authority estimates that 16,882 Danish trial subjects will participate in the 294 trials that were applied for in 2013.
Sundhedsstyrelsen forventer at arbejdet er afsluttet i september 2014. 
The Danish Health and Medicines Authority expects that this work is completed in September 2014.
Lægemiddelstyrelsen følger Kommissionens ”Guidance concerning the Braille requirements for labelling and the package leaflet”. 
The Danish Health and Medicines Authority follows the Commission's “Guidance concerning the Braille requirements for labelling and the package leaflet”.
Lægemiddelstyrelsen følger Kommissionens ”Guidance concerning the Braille requirements for labelling and the package leaflet”. 
The Danish Health and Medicines Authority follows the Commission’s “Guidance concerning the Braille requirements for labelling and the package leaflet”.
Sundhedsstyrelsen har bedt virksomheden tilbagekalde medicinen (batchen). 
The Danish Health and Medicines Authority has asked the company to recall the medicine (the batch).
Vi har i Sundhedsstyrelsen efterfølgende besluttet, at vi selv varetager udsendelse af DHPC. 
The Danish Health and Medicines Authority has decided that we will send out the DHPCs.
Sundhedsstyrelsen har overholdt de fastsatte sagsbehandlingstider med 98%, og 10% har været behandlet gennem den fælles europæiske procedure VHP. 
The Danish Health and Medicines Authority has met 98% of the fixed assessment times, and 10% have been reviewed through the common European Voluntary Harmonisation Procedure (VHP).
Sundhedsstyrelsen har deltaget i forhandlingerne om forslaget og deltager nu i europæiske og nationale arbejdsgrupper for at forberede ikrafttrædelse af forordningen. 
The Danish Health and Medicines Authority has participated in the negotiations on the proposal and is now represented in European and national working groups to prepare the coming into force of the regulation.
Sundhedsstyrelsen har udarbejdet en midtvejsstatus for aktiviteter i handlingsplanen for regionernes brug af lægemidler til igangsætning af fødsler. 
The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour.
Sundhedsstyrelsen har udarbejdet ny status for Pradaxa® (dabigatran etexilat) og Xarelto® (rivaroxaban), side 5 
The Danish Health and Medicines Authority has prepared a new status report for Pradaxa® (dabigatran etexilate) and Xarelto® (rivaroxaban) (p 5)
Sundhedsstyrelsen har tidligere informeret om EU-gennemgangen: EU's bivirkningskomité bekræfter fordelene ved alle typer p-piller 
The Danish Health and Medicines Authority has previously informed about the PRAC review: PRAC confirms the benefits of all combined hormonal contraceptives (in Danish)
Sundhedsstyrelsen fastholder anbefaling om influenzavaccination, side 5 
The Danish Health and Medicines Authority maintains influenza vaccine recommendation (p 5)
Lægemiddelstyrelsen kan hjælpe med at svare på spørgsmål til enkelte dele af ansøgningen samt procedurespørgsmål, men vi kan ikke evaluere hele dossieret inden ansøgning. 
The Danish Health and Medicines Authority may assist by answering questions about some parts of the application as well as procedural questions; however, we cannot evaluate the entire dossier until the application is submitted.
Sundhedsstyrelsen har jævnlige koordinationsmøder med: Sekretariaterne for den nationale og de regionale etiske kommitter, De lægevidenskabelige Selskaber og Lægeforeningen, GCP enhederne, Lægemiddelindustriens udvalg for klinisk udvikling og Genterapi udvalget (miljøstyrelsen, arbejdstilsynet og sundhedsstyrelsen). 
The Danish Health and Medicines Authority meets regularly with: The secretariats of the national and regional ethics committees, the Organization of Danish Medical Societies and the Danish Medical Association, the GCP units, the pharmaceutical industry's committee for clinical research and gene therapy committee (Danish Environmental Protection Agency, Danish Working Environment Authority and the Danish Health and Medicines Authority).
Sundhedsstyrelsen har overholdt de fastsatte sagsbehandlingstider med 88 %, og 25 % af ansøgningerne har været behandlet gennem den fælles europæiske procedure VHP. 
The Danish Health and Medicines Authority met 88% of the fixed assessment times, and 25% of the applications were reviewed through the common European Voluntary Harmonisation Procedure (VHP).
Sundhedsstyrelsen overvåger og kontrollerer produktfejl på lægemidler på det danske marked for at beskytte mennesker og dyrs sundhed. 
The Danish Health and Medicines Authority monitors and checks product defects of medicines on the Danish market to safeguard people as well as animals.
Sundhedsstyrelsen deltager nu i europæiske og nationale arbejdsgrupper for at forberede ikrafttrædelse af forordningen. 
The Danish Health and Medicines Authority now participates in European and national working groups to prepare the coming into force of the regulation.
Sundhedsstyrelsen har deltaget i forhandlinger i rådsregi om det af EU Kommissionen fremsatte forslag til nye europæisk lovgivning om kliniske forsøg med lægemidler, som er blevet vedtaget i foråret 2014. 
The Danish Health and Medicines Authority participated in the negotiations in the Council for the European Commission's proposal for new European legislation on clinical trials of medicinal products, which was adopted in the spring of 2014.
Sundhedsstyrelsen deltager i forhandlingerne om dette forslag i rådsregi. 
The Danish Health and Medicines Authority participates in the negotiations for this proposal in the Council.
Sundhedsstyrelsen modtog 306 ansøgninger og afgjorde 294. 291 forsøg fik en tilladelse i 2013. 
The Danish Health and Medicines Authority received 306 applications and reviewed 294. 291 trials were authorised in 2013.
Sundhedsstyrelsen foretager en grundig behandling af alle indberetninger, og vurderer i samarbejde med markedsføringsindehaveren, eller dennes repræsentant, hvorvidt produktfejlen kan føre til en tilbagekaldelse. 
The Danish Health and Medicines Authority thoroughly evaluates all reports and assesses in cooperation with the marketing authorisation holder or representative whether the product defect could lead to a withdrawal.
Sundhedsstyrelsen advarer mod at anvende slankemidlerne 'Slimex 15' og 'Slimex 15 new Formula, som sælges på internettet. 
The Danish Health and Medicines Authority warns against taking the weight-loss products Slimex 15 and Slimex 15 New Formula that are sold on the internet.
Sundhedsstyrelsens analyse af melatonin-brugere under 25 år 
The Danish Health and Medicines Authority's analysis of melatonin users under the age of 25
Sundhedsstyrelsens årsrapport for overvågning af bivirkninger 2012, side 10 
The Danish Health and Medicines Authority's annual pharmacovigilance report 2012 (p 10)
Sundhedsstyrelsens rapport om NSAID'er - en undersøgelse af antal brugere, indberettede formodede bivirkninger og utilsigtede hændelser 
The Danish Health and Medicines Authority's report on NSAIDs – a study of the number of users, reported suspected adverse reactions and inadvertent incidents
Sundhedsstyrelsen, SKAT og politiet har deltaget i den netop overståede Operation PANGEA VIII - en verdensomspændende aktion med fokus på at bekæmpe ulovligt salg af medicin på internettet og gøre forbrugerne opmærksomme på de risici, som findes ved køb af medicin på nettet. 
The Danish Health and Medicines Authority, the Danish customs and tax authorities (SKAT) and the Danish Police participated in the recent Operation PANGEA VIII - a global operation combating illegal online sale of medicines and making consumers aware of the risks associated with buying medicines online.
Fra Danmark deltog Sundhedsstyrelsen, SKAT, politiet og Fødevarestyrelsen i aktionen, med assistance fra Lægemiddelindustriforeningen og Dansk Brand- og Sikringsteknisk Institut. 
The Danish Health and Medicines Authority, the Danish customs and tax authorities (SKAT), the Danish Police and the Danish Veterinary and Food Administration participated in the operation and were assisted by the Danish Association of the Pharmaceutical Industry and the Danish Institute of Fire and Security Technology.