natgillin/translations-raw huggingface dataset:
Derimod er der sket en stigning i indberetninger fra andre lægemiddelmyndigheder og fra fremstillere eller importører. 
However, the number of reports from other pharmaceutical authorities and from manufacturers or importers has increased.
Personen skal dog have sin gang i virksomheden i tilstrækkeligt omfang under hensyntagen til aktiviteten i virksomheden. 
However, the person must be at the company regularly and to an adequate extent with due consideration to the company's activities.
Det planlagte antal inkluderede patienter inden for cancerområdet udgør dog ikke en tilsvarende andel, idet 18 % af det totale antal planlagte forsøgspersoner i Danmark er patienter inden for cancerområdet. 
However, the planned number of included patients in the cancer field does not account for an equivalent share as 18% of the total number of planned trial subjects in Denmark are patients within the cancer field.
Dog ændres den nuværende Lægemiddellov og Komitélov allerede 1. juli 2016, således at det præciseres, at sponsor, monitor og Lægemiddelstyrelsens GCP-inspektører har direkte adgang til forsøgspersonernes patientjournal. 
However, the present Danish Medicines Act and the Danish act on research ethics committees have been amended at 1 July 2016 and specify that the sponsor, monitor and the Danish Medicines Agency's GCP inspectors have direct access to trial subjects' patient records.
Dog ændres den nuværende Lægemiddellov og Komitélov allerede 1. juli 2016 således, at det præciseres, at sponsor, monitor og Lægemiddelstyrelsens GCP-inspektører har direkte adgang til forsøgspersonernes patientjournal. 
However, the present Danish Medicines Act and the Danish act on research ethics committees will be amended at 1 July 2016 and specify that the sponsor, monitor and the Danish Medicines Agency's GCP inspectors have direct access to trial subjects' patient records.
Papirbaserede ansøgninger er dog markant mere ressourcekrævende at modtage og mindre overskuelige at sagsbehandle. 
However, the receipt and assessment of paper-based applications are very resource-demanding.
Medicintilskudsnævnet anbefaler dog, at det generelt klausulerede tilskud til enkelte former af nitrater bortfalder, samt at det generelle tilskud til adrenalin i ampuller bortfalder. 
However, the Reimbursement Committee recommends that general conditional reimbursement for certain types of nitrates should be eliminated as well as general reimbursement for adrenaline ampoules.
Kravet om, at en sagkyndige person skal have modtaget undervisning i samtlige, ovennævnte grundfag kan fraviges. 
However, the requirement that a QP must have studied all of the above-mentioned basic subjects can be waived.
Der er imidlertid skærpede krav til dokumentation i forbindelse med kliniske forsøg. 
However, the requirements for documentation relating to clinical trials are more stringent.
Resultatet af samarbejdet med patientmålgrupper skal dog være på engelsk. 
However, the result of the cooperation with patient target groups must be in English.
Dataansvarlige bør opfordres til at 
However, the result of those considerations
Resultaterne indikerer dog, at der kan opstå sjældne tilfælde, hvor den faste tandprotetik utilsigtet indeholder uhensigtsmæssige metaller eller produkter forbyttes. 
However, the results indicate that in rare cases fixed dental prosthetics may unintentionally contain inappropriate metals or products may be swapped by mistake.
Retten til at engrosforhandle de fremstillede lægemidler dækker dog kun den adresse, som har en fremstillertilladelse. 
However, the right to distribute the manufactured medicines by wholesale only covers the site address holding the MIA.
Men ved siden af dette gælder fortsat reglerne om lægemidler, kosttilskud, fødevarer m.v., som fortsat skal overholdes. 
However, the rules regulating medicines, food supplements, food, etc. still apply in parallel and must still be observed.
Andelen af nationale forsøg er dog på samme niveau som i 2014 med 37,1 % af det samlede antal ansøgninger. 
However, the share of national trials is at the same level as in 2014 and accounts for 37.1% of the total number of applications.
Sponsor skal dog sikre, at forsøget på de forsøgssteder, der ikke falder ind under IND, overholder reglerne i 21 CFR 312.120, “Foreign clinical studies not conducted under an IND”, hvilket kræver, at forsøget udføres i overensstemmelse med god klinisk praksis (GCP), og at FDA kan validere forsøgsdata under en inspektion på forsøgssteder, hvis FDA vurderer, at det er nødvendigt. 
However, the sponsor must ensure that the non-IND sites complies with 21 CFR 312.120, “Foreign clinical studies not conducted under an IND.”, which requires that the trial be conducted in accordance with good clinical practice (GCP) and that FDA is able to validate the data from the trial through an onsite inspection if the FDA deems it necessary.
Standardgebyret dækker imidlertid ikke vurdering af bioækvivalensdata eller eventuelle ekstravurderinger af non-klinisk, klinisk eller veterinærklinisk karakter. 
However, the standard fee does not cover an assessment of bioequivalence data or any additional assessments of a non-clinical, clinical or veterinary clinical nature.
Behandlingen er imidlertid dyrere end tidligere metoders behandling, og da den er ny, er der naturligvis ikke meget data om langtidseffekten. 
However, the treatment is far more expensive than any previous types of treatment, and since the treatment is relatively new, there are no adequate data on the long-term effects.
Der er dog generelt for mange afvigelser fortsat. 
However, there are still too many deficiencies overall.
Dog skal udstyr efter mål, system- og behandlingspakker og udstyr beregnet til klinisk afprøvning ifølge lovgivningen ikke CE-mærkes. 
However, there is no legal requirement for CE marking of custom-made devices, system and medical treatment packages and devices for clinical investigation.
Derimod ses der en del udvikling af radioaktive sporstoffer og lægemidler i regi af kliniske forsøg og udleveringstilladelser. 
However, there is some development in radioactive traces, medicinal products in clinical trials and compassionate use permits.
Det betyder ikke, at der ikke kan være tilfælde, hvor den ene type kan være at foretrække frem for den anden, eller at der kan være behov for kombinationsbehandling af ACEhæmmer og angiotensin-II antagonist, men det er nævnets vurdering, at der som altovervejende hovedregel i daglig klinisk praksis ikke er et fagligt relevant grundlag for at skelne mellem de to grupper af lægemidler. 
However, there may still be some cases where the one type may be preferred over the other, or cases where a combination of an ACE inhibitor and an angiotensin II antagonist may be required, but it is the opinion of the Committee that in everyday clinical practice, there is no scientifically relevant basis for distinguishing between these two groups of medicinal products.
Der er derimod flere indberetninger fra andre lægemiddelmyndigheder og fra fremstillere eller importører end tidligere år. 
However, there were more reports from other pharmaceutical authorities and from manufacturers or importers than previous years.
Der vil dog være en overgangsordning indtil alle kommercielle sponsorer er registreret i SUSAR-databasen. 
However, there will be an interim arrangement until all commercial sponsors have been registered in the SUSAR database.
Disse forskelle må dog ikke have betydning for effekt og bivirkninger sammenlignet med referencelægemidlet. 
However, these differences must not have an impact on the efficacy and adverse reactions compared with the reference medicinal product.
Men medicinsk udstyr skal altid være CE-mærket, før det kommer på markedet. 
However, they must be CE marked, before they are placed on the market.
Dette gælder dog ikke, hvis forhandleren alene har tilladelse til at forhandle lægemidler til behandling af gener ved rygeafvænning. 
However, this does not apply if the outlet has permission to sell smoking cessation products only.
Det gælder dog ikke for lægemidlerne Forsteo og Preotact, hvor de vejledende kriterier for enkelttilskud ikke ændres. 
However, this does not apply to the medicines Forsteo and Preotact, whose guiding criteria for single reimbursement are not changed.
Denne virkning er imidlertid ikke dokumenteret. 
However, this effect has not been documented.
Dette er dog under forudsætning af, at afvigelserne skyldes hensynet til at kunne udarbejde pakningsmateriale, som skal være fælles for flere nordiske/EU/EØS-lande. 
However, this is on the terms that the deviations are intended to facilitate the making of packaging material common to several Nordic/EU/EEA countries.
Denne praksis blev ikke fulgt i VALUE-studiet, hvor skiftet varede fra 3-6 måneder. 
However, this practice was not observed in the VALUE study, where the change took 3-6 months.
Vi er dog nødt til at tage forbehold for den endelige godkendelse af navnet, fordi der i perioden indtil lægemidlet evt. får udstedt en markedsføringstilladelse, kan blive godkendt andre lægemidler med navne, man kan forveksle med det ansøgte lægemiddelnavn. 
However, this procedure is subject to the final approval of a name, because in the period until a marketing authorisation has been granted for a medicinal product, other medicinal product names may have been approved that can be confused with the medicinal product name applied for.
Denne forordning gælder dog for dataansvarlige eller databehandlere, som tilvejebringer midlerne til behandling af personoplysninger til sådanne personlige eller familiemæssige aktiviteter. 
However, this Regulation applies to controllers or processors which provide the means for processing personal data for such personal or household activities.
Dette er dog en mindre andel end i 2014, hvor andelen var 62 %. 
However, this share is somewhat lower than in 2014 (62%).
Dette forudsætter en gyldig begrundelse i særlige forhold omkring forsøgsdesign, præparatkarakteristika og/eller patientpopulationen. 
However, this should be explicitly justified in special circumstances arising from the study design, product characteristics and/or patient population.
Det er dog en forudsætning, at der findes en procedure for denne påfyldning, som påfylderen er uddannet i, og som sikrer, at der på intet tidspunkt er tvivl om, hvilken batch der er i brugerens/patientens beholder. 
However, under the condition that there is a filling procedure which a person is qualified to perform, and which ensures that there is absolutely no doubt of which batch that is in the user’s/patient’s tank.
Vi forestiller os imidlertid at alle berørte parter har en interesse i, at varenummeret er indeholdt i koden. 
However, we believe that all parties involved would prefer that the item number is contained in the identifier.
Vi opfordrer dog til, at du udfylder så mange ikke-obligatoriske felter som muligt. 
However, we encourage you to fill in as many of the non-mandatory fields as possible.
Dog mener vi, at man bør have for øje, at der ved et omfattende off-label-forbrug ikke foreligger tilstrækkelig dokumentation for medicinens sikkerhed og effekt i forhold til denne patientgruppe. 
However, we find it necessary to highlight that when considerable off-label use occur, there is no adequate documentation available for the medicine's safety in relation to the patient group concerned.
Det er godt, at vi har dygtige medarbejdere med høj ekspertise på lægemiddelområdet, som vil kunne kompensere den ekspertise, vi mister. 
However, we have highly skilled employees with great expertise in the pharmaceutical area who are able to make up for the expertise we now lose.
Vi foretrækker dog, at den ønskede slottid ikke ligger meget mere end 1½ år frem i tiden. 
However, we recommend that the requests are limited to no longer than 1½ years from the date of the request.
Vi henstiller dog til, at antallet holdes på et niveau, der ikke vil belaste de administrative byrder for såvel virksomheden som for Lægemiddelstyrelsen ved hyppige opdateringer af § 39-tilladelsen. 
However, we request companies to keep the number of qualified persons at an appropriate level in order not to burden the administrative processes for both the companies and the Danish Health and Medicines Authority in connection with frequent updates of section 39 authorisations.
Hvad angår forbruget af dihydropyridinerne er det dog vores umiddelbare vurdering, at andelen af personer i behandling med de dyre dihydropyridiner er for højt, idet en større andel af disse patienter med samme effekt vil kunne behandles med de billigere dihydropyridiner amlodipin og felodipin. 
However, when it comes to the consumption of dihydropyridines, we believe that the number of patients in treatment with the expensive dihydropyridines is too high as many of these patients would gain the same effect from treatment with the less expensive dihydropyridines amlodipine and felodipine.
Til gengæld vil Lægemiddelstyrelsen ikke holde sig til fast definerede tidsperioder for de enkelte sagsfaser, i det konkrete sagsforløb for en ansøgning. 
However, when the Danish Medicines Agency assesses an application, it will not keep to fixed time periods within the individual phases.
Arbejdsdokumenter kan dog også sendes pr. CD/DVD, hvis det tydeligt fremgår af såvel følgebrev som CD/DVD’ens mærkning, at der udelukkende er tale om arbejdsdokumenter. 
However, working documents can also be submitted on CD/DVD if it is clearly stated in the cover letter and it appears from the imprint/label of the CD/DVD that the submission concerns working documents only.
Arbejdsdokumenter skal dog altid sendes i elektronisk form (se nedenfor). 
However, working documents must always be submitted electronically (see below).
Her kan man søge om tilskud hos kommunen. 
However, you can apply to your municipality for reimbursement for that.
Derimod benytter dansk sig af en række andre udsagnsord, når der er tale om at videregive en kort besked (eksempler: uformelt, "sige noget til nogen", formelt, "informere nogen om noget", neutralt, "give nogen besked om noget"). 
However, you can use many other verbs in Danish when you want to express the meaning of giving a short message (examples: informal: "sige noget til nogen", formal: "informere nogen om noget", neutral: "give nogen besked om noget").
Men man kan ikke både få tilskud efter de danske regler om tilskud til medicin og refusion efter reglerne om det blå EU-sygesikringskort til samme medicinkøb. 
However, you cannot obtain reimbursement under the Danish rules on reimbursement of medicines and under the European Health Insurance Card for the same purchase of medicine.
Dog skal I kontakte os i forvejen for at få konfigureret jeres ID i vores system. 
However, you have to let us know in advance so that we can configure your ID in our system.
Der gøres dog opmærksom på, at påførelse af sikkerhedselementer på sådanne lægemidler er et krav, inden lægemidlerne frigives til salg eller distribution. 
However, you should be aware that the placing of safety features on such medicinal products is required once the medicines are released for sale or distribution.
Du skal dog angive en entydig reference til den dokumentation, du tidligere har indsendt (dato på e-mail, e-mail-afsender, filnavn og dokumentnumre), og dokumentationen skal stadig være gældende. 
However, you should state a clear reference to the documentation that you submitted previously (date of your e-mail, e-mail sender, file name and document numbers), and the documentation must still be valid.
HPLC-metode for at påvise indhold af nikotin og estimere semikvantitativt indhold af tilstedeværende nikotin. 
HPLC method to identify nicotine as well as estimate a semi-quantitative level of nicotine present.
HPV-test, apps, der tester for depression og gentest, der kan beregne sandsynligheden for at udvikle kræft, og andre sygdomme er bare nogle af de mange hjemmetest/selvtest, som er kommet på markedet de seneste år. 
HPV tests, depression test apps and genetic tests calculating the probability of developing cancer and other diseases are some of the many home tests and self-tests that have been placed on the market during the past years.
HPV-vaccination beskytter mod livmoderhalskræft 
HPV vaccination protects against cervical cancer
HPV-vacciner kan ligesom andre vacciner og medicin have bivirkninger. 
HPV vaccines may cause adverse reactions, just like other vaccines and medicines.
https://eudract.ema.europa.eu/ under dokumenter. 
http://eudract.ema.europa.eu//document.html under Guidance Documents.
Hum. 
Human
Human og veterinær 
Human and veterinary
Humane og veterinære lægemidler 
Human and veterinary medicines
Humane knoglesubstitutter er en erstatning for et naturligt knoglegraft, og er ofte produceret på grundlag af kalciumbaserede keramikker, vækstfaktorer, knogledannende celler eller en kombination af disse. 
Human bone substitutes replace natural bone graft and are often based on calcium-based ceramics, growth factors, bone-forming cells or a combination thereof.
DCP procedurer 
human DCP procedures
Humane lægemidler 
Human medicinal products
lægemidler til mennesker godkendt efter MRP 
human medicinal products authorised according to the MRP,
For humane lægemidler: 
Human medicinal products:
Humane lægemidler 
Human medicines
Humanlægemidler 
Human medicines
Humane lægemidler: 71 % af sagerne overholder resultatkravet på 30 dage i opstartsfasen (gennemsnitligt 22 dage). 
Human medicines: 71 % of the cases finished within the performance requirement's maximum of 30 days (22 days on average).
Plasmaproteinkoagulationsfaktorer, humane, med plasminhæmmer og von Willebrand faktor 
Human plasma protein coagulation factors with plasmin inhibitors and von Willebrand factor
HV = Håndkøb, ikke apoteksforbeholdte lægemidler til dyr 
HV = OTC medicines permitted for sale outside pharmacies, for veterinary use
HV betyder, at lægemidlet er til veterinær brug (til dyr). 
HV means that the medicine is for veterinary use (for animals).
HX = Håndkøb, ikke apoteksforbeholdte lægemidler til mennesker, med krav om 
HX = OTC medicines permitted for sale outside pharmacies, for human use, with
HX betyder, at du uden for apoteket kun kan købe én pakning af hvert af de lægemidler, der er optaget i Lægemiddelstyrelsens register over godkendte lægemidler under udleveringsgruppe HX. 
HX means that, outside pharmacies, you can only buy one package of each of the medicines which are listed in the Danish Medicines Agency's register of authorised medicines in dispensing group HX.
HX-lægemidler kan kun købes i små pakningsstørrelser uden for apoteket. 
HX medicines are only available in small pack sizes outside pharmacies.
HX18 betyder det samme som HX, dog med tilføjelsen at du skal være 18 år for at købe smertestillende lægemidler og visse midler mod transportsyge i denne gruppe. 
HX18 means the same as HX, but you must be over 18 years old to buy painkillers and certain products for motion sickness in this group.
Hybrid ansøgning (art. 10.3/13.3) med kliniske studier vedrørende effekt og/eller sikkerhed 
Hybrid application (art. 10.3/13.3) with clinical studies concerning efficacy and/or safety.
Hybrid ansøgning (art. 10.3/13.3) uden kliniske studier vedrørende effekt og/eller sikkerhed 
Hybrid application (art. 10.3/13.3) without clinical studies concerning efficacy and/or safety
Hydrochlorthiazid (HCTZ) og brug under amning samt samlede tekster for SmPC og PL for ACE-hæmmere, alene og i kombination med HCTZ under graviditet (pdf-fil) 
Hydrochlorothiazide (HCTZ) and use in lactation + consolidated wording for the SmPC and PL of ACE-inhibitors alone or in combination with HCTZ in pregnancy and lactation (PDF file in Danish)
hydrochlorthiazid er ikke markedsført som enkeltstof 
hydrochlorothiazide is not marketed as a single substance
hydrochlorthoazid er ikke markedsført som enkeltstof 
hydrochlorothiazide is not marketed as a single substance
hydrochlortihiazid er ikke markedsført som enkeltstof 
hydrochlorothiazide is not marketed as a single substance
Hydrochlorthiazid er ikke markedsført som enkeltstof. 
Hydrochlorothiazide is not marketed as an individual substance.
hydrochlorthiazid* 
hydrochlorothiazide*
hydroxyzin (N05BB01) 
hydroxyzine (N05BB01)
J. Hypertension 2007; 25:1105-1187 (www.jhypertension.com) 
Hypertension 2007; 25:1105-1187 (www.jhypertension.com)
Hypertension er en kendt bivirkning ved infliximab, og i produktresuméet for methotrexat er cerebrale tromboembolier angivet som en sjælden bivirkning. 
Hypertension is a known adverse reaction of infliximab, and in the SmPC for methotrexate, cerebral thromboembolism is indicated as a rare adverse reaction.
I ) Generelle krav 
I ) General requirements
I 2016 har 92 % af alle ansøgere modtaget første svar inden for 42 kalenderdage, mens de resterende ansøgninger om kliniske forsøg med lægemidler modtog første svar inden for 60 kalenderdage. 
I 2016, 92% of all applicants received a first reply within 42 calendar days, and the remaining applications for clinical trials of medicinal products received a first reply within 60 calendar days.
Undertegnede er desuden bekendt med, at de oplysninger, som Sikkerhedsadministratoren afgiver til Lægemiddelstyrelsen via DKMAnet er bindende for virksomheden. 
I am also aware that the information that the Security Administrator gives to Danish Health and Medicines Authority via DKMAnet is binding on the company.
Jeg glæder mig også til at skulle lede en myndighed, som er borgernes garant for, at der er effektive og sikre lægemidler til rådighed”, siger Thomas Senderovitz. 
I am also looking forward to heading an agency that works to ensure that effective and safe medicinal products are available to citizens,” says Thomas Senderovitz.
Undertegnede er bekendt med, at virksomheden har ansvaret for, at der om nødvendigt foreligger fornøden fuldmagt til at bemyndige personer udenfor virksomheden. 
I am aware that the company is responsible for persons outside the company being duly authorised if necessary.
Jeg glæder mig derfor til at lede dette vigtige område, som har en afgørende indflydelse på, at patienterne får den bedst mulige behandling,” siger Janne Lehmann Knudsen. 
I am looking forward to heading this important area, which is decisive for offering patients the best possible treatment,” says Janne Lehmann Knudsen.
Jeg glæder mig meget til, at de bliver en del af vores organisation og faglige profil,” siger han. 
I am looking forward to welcoming them to join our organisation and professional profile,” he says.
Jeg er sikker på, at efteråret byder på en masse spændende opgaver for os. 
I am sure this autumn will hold many new exciting tasks for us.
Derfor er jeg utrolig glad for den aftale, vi i dag har indgået med de japanske lægemiddelmyndigheder”, slutter Thomas Senderovitz. 
I am therefore delighted about the Confidential Arrangements we have signed with the Japanese drug regulatory authorities today", finishes Thomas Senderovitz.
Både ved de store debatter i teltene, og når enkelte borgere tager fat i armen på mig efter en debat og gerne lige vil drøfte et spørgsmål på tomandshånd uden det store publikum. 
I get just as excited every year about how directly I can talk to citizens and stakeholder organisations when I am over there.
Hver gang bliver jeg lige begejstret for den direkte dialog, jeg har med borgere og interesseorganisationer derovre. 
I get just as excited every year about how directly I can talk to citizens and stakeholder organisations when I am over there.
Jeg takker for den tillid, som de andre lande viste os og for den opbakning, København har fået fra Europa” siger Thomas Senderovitz. 
I would like to thank the other EU countries for the confidence they showed in us and for their support to Copenhagen,” says Thomas Senderovitz.
Det er jeg overbevist om, at vi kommer til at få gavn af fra dag et”, siger Lægemiddelstyrelsens direktør Thomas Senderovitz. 
I'm convinced that we will benefit from his experience from day one,” says Thomas Senderovitz, Director General of the Danish Medicines Agency.
Undertegnede erklærer at være tegningsberettiget for virksomheden. 
I, the undersigned, declare that I am authorised to sign for the company.
I-131 natriumjodid-kapsler er blevet testet. 
I-131 Sodium Iodide capsules have been tested.
I. Skriv dansk 
I. Write in Danish