natgillin/translations-raw huggingface dataset:
For at kunne bevise dette, er det nødvendigt at have recept på medicinen, når du indfører produktet til Danmark, og mens du opholder dig i Danmark. 
To be able to prove this, you need to carry a prescription for the medicine when you import it to Denmark and while you stay in Denmark.
For at sponsorer kan rapportere SUSARs elektronisk til Lægemiddelstyrelsen, skal deres Sender ID være registreret i vores system, og de skal have udført test med EMA og Lægemiddelstyrelsen. 
To be able to report SUSARs electronically to the Danish Medicines Agency, the Sponsor's Sender ID must be registered in our system and the Sponsor must have tested the connection with the EMA and the Danish Medicines Agency.
At være et attraktivt land for kliniske forsøg med lægemidler er et særdeles vigtigt element for Regeringens ambitioner om, at Danmark skal være en førende life science nation. 
To be an attractive country for clinical trials of medicines is a very important element in the Danish government’s ambitions to make Denmark a leading life science nation.
For at blive godkendt, skal det dokumenteres at et biosimilært lægemiddel har den samme kvalitet, effekt og sikkerhedsprofil som referencelægemidlet. 
To be authorised as a medicinal product, it must be documented that a biosimilar medicinal product has the same quality, efficacy and safety profile as the reference medicinal product.
For at en app kan blive kategoriseret som medicinsk udstyr, skal den enten kunne bruges til at diagnosticere eller behandle. 
To be classified as a medical device, an app must be able to make a diagnosis or treat a patient.
Minimum 50 % af forretningens omsætning skal udgøres af de nævnte typer medicinsk udstyr, for at forretningen betragtes som en specialforretning. 
To be considered a specialised store, a minimum of 50% of the store's sales must be constituted by the above-mentioned types of medical device.
For at betragtes som steril eller ikke fertil, må man almindeligvis være kirurgisk steriliseret (vasektomi/bilateral tubektomi, hysterektomi og bilateral ovarektomi) eller være postmenopausal, defineret som udebleven menstruation i mindst 12 måneder før studie indrullering. 
To be considered sterilised or infertile, subjects must generally have undergone surgical sterilisation (vasectomy/bilateral tubectomy, hysterectomy and bilateral ovariectomy) or be postmenopausal defined as no menses for 12 months or more prior to enrolment.
Opbevares utilgængeligt for børn 
To be kept out of the reach of children
Til at starte med skal alle anmode om eksportcertifikater via certificates@dkma.dk . 
To begin with, all requests for export certificates must be sent to certificates@dkma.dk .
Til at starte med skal alle anmode om eksportcertifikater via certificates@dkma.dk. 
To begin with, all requests for export certificates must be sent to certificates@dkma.dk.
For bedre at forstå de vilkår som gælder for behandlingerne, kan det være en god idé først at læse vores databeskyttelsespolitik . 
To better understand the terms that apply to these operations, we suggest you first read our data protection policy.
For at skærpe opmærksomheden på at indberette bivirkninger til Sundhedsstyrelsen lancerede vi i 2012 en bivirkningskampagne rettet mod sundhedspersonale i plejesektoren. 
To call attention to the importance of reporting adverse reactions to the DHMA, we launched an adverse reaction campaign in 2012 targeted at healthcare professionals in the care sector.
Dækning af omkostninger Lægemiddelstyrelsens kontrol, jf. §3 stk. 2. 
To cover expenses for the Danish Medicines Agency's supervision, cf. section 3(2)
For at en recept kan indløses i et andet EU-EØS-land end det land recepten er udstedt i skal recepten som minimum indeholde følgende oplysninger m.v.: 
To dispense a prescription in another EU/EEA country than the country in which the prescription was issued, the prescription must as a minimum provide the following information:
I så fald skal der sættes kryds i både ”ændring” og ”forlængelse”, og hele ansøgningsskemaet skal udfyldes i henhold punkt 3) om ansøgning om forlængelse af eksisterende virksomhedstilladelse. 
To do so, both "change" and "renewal" must be ticked, and the entire application form must be completed in pursuance of item 3) Application for renewal of existing authorisation.
Det kræver, at de fremmødte vurderer, at en udsættelse af sagen vil medføre væsentlige ulemper for den eller dem, sagen handler om, eller betyde at væsentlige sundhedsmæssige hensyn vil blive tilsidesat. 
To do so, the attending members must find that postponing the case would be of significant inconvenience to the individual or individuals of the case, or would jeopardise important health considerations.
Det kræver, at de fremmødte vurderer, at en udsættelse af sagen vil medføre væsentlige ulemper for den eller dem, sagen handler om, eller betyde at væsentlige sundhedsmæssige hensyn vil blive tilsidesat. 
To do so, the attending members must find that postponing the case would be of significant inconvenience to the individual or individuals of the case, or would jeopardize important health considerations.
Det gør du ved at sende en variationsansøgning. 
To do so, you must submit a variation application.
For at dokumentere en ensartet produktion skal der være vedlagt ovenstående analysecertifikater for mindst 3 batcher, og analyseresultaterne skal ligge inden for grænseværdierne af hhv. deklareret indhold og urenheder. 
To document a consistent production, the above-mentioned certificates of analysis must be enclosed for at least 3 batches, and the analytical results must be within the acceptance criteria of declared content and impurities, respectively.
For at downloade interaktionsdatabasen skal du følge vejledningen: Sådan downloader du interaktionsdatabasen som XML-fil (pdf). 
To download the Drug Interaction Database, follow these guidelines: How to download the Drug Interaction Database as an XML file (PDF).
Det påvirker mulighederne for at sige noget samlet om dem. For at få god information ud af en metaanalyse skal studierne i et vist omfang være sammenlignelige i deres opsætning. 
To draw good information from a meta-analysis, the set-up of the trials included must be reasonably comparable.
For at sikre en smidig overgang for dem, der berøres af tilskudsændringerne, vil vi bede apotekerne om i de kommende måneder ved receptekspeditioner på de berørte lægemidler at opfodre kunderne til ved næste receptfornyelse - og inden 15. november - at tale med lægen om den fremtidige behandling. 
To ensure a smooth transition for those patients affected by the reimbursement changes, we encourage the pharmacists, when dispensing prescriptions for the affected medicinal products over the coming months, to ask their customers to talk to their general practitioner about their future treatment when their prescription is next up for renewal - and before 15 November.
For at sikre en smidig overgang for dem, der berøres af tilskudsændringerne, vil vi bede apotekerne om i de kommende måneder ved receptekspeditioner på de omhandlede lægemidler at opfordre kunderne til ved næste receptfornyelse - og inden 15. november - at tale med lægen om den fremtidige behandling. 
To ensure a smooth transition for those patients affected by the reimbursement changes, we encourage the pharmacists, when dispensing prescriptions for the affected medicinal products over the coming months, to ask their customers to talk to their general practitioner about their future treatment when their prescription is next up for renewal - and before 15 November.
For at sikre en målrettet og produktspecifik overvågning af nye biologiske og biosimilære lægemidler og i sidste ende en tryg og sikker behandling af patienterne har Lægemiddelstyrelsen i samarbejde med Sundheds- og Ældreministeriet udarbejdet en handlingsplan. 
To ensure a targeted and product-specific monitoring of new biological and biosimilar medicinal products and ultimately safe treatment of patients, the Danish Medicines Agency and the Danish Ministry of Health have prepared an action plan.
For at sikre let tilgængelighed af materialet skal firmaer, der har markedsføringstilladelserne (MAH'er) for de relevante præparater, endvidere sørge for, at papirkopier af materialet bliver tilgængelige for de relevante læger. 
To ensure easy access to the material, companies holding the marketing authorisations (MAHs) for the relevant products must make sure that paper copies of the material become available to the relevant doctors.
For at sikre let tilgængelighed af materialet skal firmaer, der har markedsføringstilladelserne (MAH’er) for de relevante præparater, endvidere sørge for, at papirkopier af materialet bliver tilgængelige for de relevante læger. 
To ensure easy access to the material, companies holding the marketing authorisations (MAHs) for the relevant products must make sure that paper copies of the material become available to the relevant doctors.
For at sikre hurtig og præcis information til vores interessenter vil meddelelser vedrørende revurdering af lægemidlers tilskudsstatus fremover som hovedregel kun blive lagt på vores netsted www.laegemiddelstyrelsen.dk under målgruppeindgangen for Virksomheder > Generelt tilskud > Revurdering af tilskudsstatus. 
To ensure fast and exact information for interested parties, future messages of reassessment of reimbursement status for medicinal products will, as a general rule, only be posted on our website www.dkma.dk under the target group entrance for Companies > General Reimbursement > Reassessment of reimbursement status.
Personoplysninger bør behandles på en måde, der garanterer tilstrækkelig 
to ensure that personal data which are inaccurate are rectified or deleted.
For at sikre at sponsor har tid til at ændre ansøgningen, er det aftalt med lægemiddelindustrien, at første svar (med enten begrundet indsigelse, 
To ensure that the sponsor has the required time to amend the application, it has been agreed with the pharmaceutical industry that the sponsor is to receive a first reply (including grounds for non-acceptance, an
For at sikre, at sponsor har tid til at ændre ansøgningen er det aftalt med lægemiddelindustrien at første svar skal være sponsor i hænde senest 42 kalenderdage efter modtagelse af en behørigt udformet ansøgning. 
To ensure that the sponsor has the required time to amend the application, it has been agreed with the pharmaceutical industry that the sponsor is to receive a reply within 42 calendar days, starting on the day the Danish Health and Medicines Authority has received a duly completed application.
For at sikre at sponsor har tid til at ændre ansøgningen, er det aftalt med lægemiddelindustrien, at første svar skal være sponsor i hænde senest 42 kalenderdage efter modtagelse af en valid ansøgning. 
To ensure that the sponsor has the required time to amend the application, it has been agreed with the pharmaceutical industry that the sponsor is to receive a reply within 42 calendar days, starting on the day the Danish Medicines Agency has received a valid application.
For at sikre hele præparatets stabilitet er det således nødvendigt at undersøge alle de relevante kemiske, fysiske og mikrobiologiske parametre, som er inkluderet i færdigvarespecifikationen. 
To ensure the stability of the entire product, it is thus necessary to investigate all the relevant chemical, physical and microbiological parameters that are included in the finished product specification.
For at sikre gennemsigtighed i arbejdet stiller vi vores viden og informationer til rådighed for omverdenen - med respekt for, at mange af de oplysninger, vi sidder inde med, er fortrolige af hensyn til enkeltpersoner eller virksomheder. 
To ensure transparency about what we do, we make our knowledge and information available to our surroundings, while respecting that much of the information we hold is confidential in regard to individual persons or companies.
For at sikre gennemsigtighed i arbejdet stiller vi vores viden og informationer til rådighed for omverdenen – med respekt for, at mange af de oplysninger, vi sidder inde med, er fortrolige af hensyn til enkeltpersoner eller virksomheder. 
To ensure transparency about what we do, we make our knowledge and information available to our surroundings, while respecting that much of the information we hold is confidential in regard to individual persons or companies.
For at skabe en gebyrbetaling, der er så tæt på den reelle sagsbehandling som muligt, er der fastsat et gebyr for behandling af en ansøgning om ny markedsføringstilladelse baseret på en standardvurdering i forhold til den dokumentation for kvalitet, sikkerhed og effekt, der typisk indsendes i henhold til ansøgningstypen. 
To establish a fee structure as similar as possible to the real assessment, a fee has been fixed for the assessment of an application for a new marketing authorisation based on a standard evaluation in relation to the documentation for quality, safety and efficacy typically submitted according to the type of application.
For at gøre det let for lægerne at ordinere rationelt, finder nævnet det vigtigt, at lægerne i ordinationsøjeblikket har let adgang til ordlyden af klausuleringsteksten. 
To facilitate rational prescription of medicine for the doctors, it is in the opinion of the Committee important that the doctors have access to the wording of the limitation text when prescribing medicine.
Med henblik på lettere at kunne identificere og håndtere indsendelser relateret til Active Substance Master File (ASMF), beder vi om, at ASMF-indehaver i følgebrevet tydeligt refererer til Lægemiddelstyrelsens journalnummer (typisk 2215-xxxx) samt anfører, at der er tale om en "ASMF-relateret indsendelse sendt på vegne af ASMF-indehaver". 
To facilitate the identification and handling of submissions related to the Active Substance Master File (ASMF), we request that the ASMF holder clearly refers to the Danish Medicines Agency's case number (typically 2215-xxxx) in the cover letter and to indicate that the submission is an "ASMF-related submission made on behalf of the ASMF holder.
Det vil fremme sagsbehandlingen, hvis det danske DMF-journalnummer (2215-XXXX) angives i ansøgningsskemaet. 
To facilitate the processing of the variation, please include the Danish DMF file number (2215-XXXX) in the application scheme.
For at lette udtagning af lægemidlet, ved en fuldklæbning, anbefales en perforering omkring blisterlommen. 
To facilitate use of the medicinal product if the label covers the entire back of the blister, we recommend a perforation around each blisterpocket.
Der findes for de mest almindeligt ansøgte typer medicin en liste over vejledende betingelser for at få tildelt enkelttilskud. 
To find out whether you could be awarded single reimbursement, we have compiled a list of guiding criteria against which single reimbursement is awarded.
For at finde RID-nummeret, skal du først installere den digitale signatur. 
To find the RID number, you must first install the digital signature.
For yderligere at skærpe opmærksomheden på at indberette bivirkninger, lancerede Lægemiddelstyrelsen i slutningen af november 2011 en landsdækkende kampagne over for plejepersonalet i alle landets kommuner. 
To further call attention to the importance of reporting side effects, the Danish Medicines Agency launched a nationwide campaign at the end of November 2011 targeted at nursing staff in all Danish municipalities.
For at kunne bruge DKMAnet skal virksomheden have udpeget en sikkerhedsadministrator (se blanket i boksen). 
To gain access to DKMAnet, companies must appoint a Security Administrator (please see the form in the box).
For at kunne bruge DKMAnet skal virksomheden have udpeget en sikkerhedsadministrator (se blanket i boksen til højre). 
To gain access to DKMAnet, the company must appoint a security administrator (please see the form in the box to the right).
For at få mere viden om bivirkninger hos børn og unge i behandling med quetiapin har Lægemiddelstyrelsen i samarbejde med en gruppe psykiatere gennemgået indberetninger om formodede bivirkninger hos børn og unge i behandling med quetiapin. 
To gain more knowledge about adverse reactions in children and adolescents treated with quetiapine, the DKMA and a group of psychiatrists have reviewed the ADR reports of suspected adverse reactions in children and adolescents treated with quetiapine.
Hvis man skal have sikker viden om bivirkninger til vacciner, er man derfor nødt til at lave større videnskabelige befolkningsstudier, der undersøger, om sygdomme forekommer oftere hos de vaccinerede sammenlignet med befolkningen i det hele taget. 
To gain reliable knowledge about adverse reactions from vaccines, major scientific population studies must be made to investigate whether diseases occur more often in people who have been vaccinated compared with the population as a whole.
For at få sikker viden om sammenhæng mellem vaccinen 
To gain reliable knowledge about the relationship between the vaccine and symptoms,
For at få den fulde virkning skal vaccinen gives, før man begynder at have sex. 
To get the full effect, the vaccine should be given before sexual initiation.
For at opnå stigende effektivitet i vores kvalitetsprocesser har vi - med kobling til leantransformationen hvor relevant - styrket fokus på: 
To improve efficiency of our quality processes, we have - with a link to the lean transformation, if relevant - increased our focus on the following:
Kildedatalisten skal være tilstrækkeligt detaljeret til, at man umiddelbart kan finde data. 
To make it easy to locate data, the list of source data must be sufficiently detailed.
at komme med anbefalinger til Lægemiddelstyrelsen vedrørende information til medicinbrugere om lægemidler og bivirkninger 
to make recommendations to the Danish Medicines Agency about information for medicine users on medicines and side effects
at komme med anbefalinger til Lægemiddelstyrelsen vedrørende information om forebyggelse af medicineringsfejl 
to make recommendations to the Danish Medicines Agency about information on the prevention of medication errors.
at komme med anbefalinger til Lægemiddelstyrelsen om tilrettelæggelse af arbejdet med at indsamle bivirkningsindberetninger og anvende tilgængelig viden om bivirkninger 
to make recommendations to the Danish Medicines Agency on how to organise the process of collecting adverse reaction reports and use available knowledge about adverse reactions (side effects)
For at sikre at kliniske forsøg overholder disse standarder, skal alle forsøg godkendes af både Lægemiddelstyrelsen og Det Videnskabsetiske Komitésystem. 
To make sure that clinical trials comply with these standards, all trials must be authorised by both the Danish Medicines Agency and the research ethics committee system.
For at sikre, at kliniske forsøg med lægemidler overholder disse standarder, skal alle forsøg, der planlægges udført i Danmark godkendes af både Lægemiddelstyrelsen og Det Videnskabsetiske Komitésystem. 
To make sure that clinical trials of medicinal products comply with these standards, all trials planned to be conducted in Denmark must be authorised by both the Danish Medicines Agency and the system of research ethics committees.
For at indskærpe din søgning, kan du også søge på styrke. 
To narrow down the search you can also add the product for strength.
Du anmelder/søger om tilladelse ved at sende en e-mail til tilknytning@dkma.dk . 
To notify or apply for permission of a relationship, please send an email to tilknytning@dkma.dk .
Du anmelder/søger om tilladelse ved at sende en e-mail til tilknytning@dkma.dk. 
To notify or apply for permission of a relationship, please send an email to tilknytning@dkma.dk.
For at opnå en fremstillertilladelse skal fremstilleren råde over mindst én sagkyndig person, som skal godkendes i Lægemiddelstyrelsen og angives på virksomhedens fremstillertilladelse. 
To obtain an MIA, the manufacturer must employ at least one QP who is authorised by the Danish Medicines Agency and named on the company's MIA.
For at få tilskud til medicin, der har generelt klausuleret tilskud i Danmark, skal lægen på recepten erklære, at du opfylder tilskudsklausulen . 
To obtain reimbursement of medicines, which carry general conditional reimbursement in Denmark, your doctor has to declare on the prescription that you meet the reimbursement condition (in Danish).
For at få tilskud til medicin, der har generelt klausuleret tilskud i Danmark, skal lægen på recepten erklære, at du opfylder tilskudsklausulen. 
To obtain reimbursement of medicines, which carry general conditional reimbursement in Denmark, your doctor has to declare on the prescription that you meet the reimbursement condition (in Danish).
Tilskuddet kan fx være betinget af, at medicinen er ordineret til nogle bestemte persongrupper eller til behandling af nogle helt bestemte sygdomme. 
To obtain reimbursement, it may be a condition that the medicine is prescribed to certain patient groups or for the treatment of specific diseases.
For at få enkelttilskud skal lægen sende en ansøgning til os og begrunde, hvorfor man bør behandles med det pågældende lægemiddel. 
To obtain single reimbursement the doctor must apply to us and document why the patient concerned needs treatment with a particular medicine.
For at kunne CE-mærke medicinsk udstyr skal fabrikanten dokumentere produktets kvalitet, sikkerhed og ydeevne 
To place a CE mark on a medical device, the manufacturer must document the product's quality, safety and performance.
For at undgå forvekslinger er det en god idé at bruge farver og typografi til at fremhæve vigtig information og til at skelne produkter. 
To prevent medicines from being confused with others, it is a good idea to use colours and typography to highlight important information and to differentiate products.
forebyggelse eller behandling af oxygenmangel (hypoxi), fx i forbindelse med anæstesi, intensiv behandling, genoplivning m.v. 
to prevent or treat oxygen deficiency (hypoxia), e.g. in connection with anaesthesia, intensive therapy, resuscitation etc.
gælde for behandlingsaktiviteter med disse formål. 
to processing activities for those purposes.
For at sikre fælles standarder og understøtte sikkerheden for brugerne bliver den statslige regulering af medicinsk udstyr i tiltagende grad et fælleseuropæisk anliggende. 
To provide common standards and support user safety, government regulation of medical devices is increasingly becoming a pan-European issue.
For at give EMA det bedst mulige grundlag for vurderingen af sammenhængen mellem POTS og Gardasil, indledte Sundhedsstyrelsen i september 2013 et samarbejde med Synkopecenteret ved Frederiksberg Hospital. 
To provide EMA with the best possible basis for assessing the relationship between POTS and Gardasil, we began cooperating with the Syncope Centre at Frederiksberg Hospital in September 2013.
skabe retssikkerhed og gennemsigtighed for erhvervsdrivende, herunder mikrovirksomheder og små og 
to provide legal certainty and transparency for economic operators, including micro, small and medium-sized
design af sådanne produkter, tjenester og applikationer og til under behørig hensyntagen til det aktuelle tekniske 
to provide specific information related to the political behaviour under former totalitarian state regimes or the
For at kvalificeres som medicinsk udstyr til IVD, skal udstyret først opfylde definitionen af medicinsk udstyr jf. ovenstående og dernæst definitionen af medicinsk udstyr til IVD i bekendtgørelsen om medicinsk udstyr til in-vitro diagnostik, § 1, stk, 2. 
To qualify as an IVD medical device, the device must firstly satisfy the definition of a medical device, cf. the above; Secondly it must satisfy the definition of an IVD medical device in section 1(2) of the Danish Executive Order on In Vitro Diagnostic Medical Devices.
For at nå dette vil vi arbejde for den nødvendige organisatoriske forankring af de tværgående opgaver i Lægemiddelstyrelsen, fx etablering af faglige tværgående kompetenceteams inden for overvågning af biologiske lægemidler. 
To reach this target, we will be working for the required organisational anchoring of crosscutting tasks at the Danish Medicines Agency, for example the establishment of professional and cross-functional competence teams within the monitoring of biological medicinal products.