natgillin/translations-raw huggingface dataset:
Dog bliver der foretaget en konkret vurdering af, om der er særlige forhold, der gør medarbejderen inhabil.
However, it will be assessed in the individual case if there are special circumstances that could disqualify the employee.
patienter, som beskriver kliniske symptomer, der ligner hyper- eller hypothyreose - i nogle tilfælde i svær grad.
However, many of the patients do not interpret these symptoms this way.
De fleste indberetninger har dog ikke omhandlet lægemidler, eller råvarestoffer anvendt til lægemidler, på det danske marked, og mange har været udenfor EU/EØS.
However, most of the reports have not involved medicines or substances contained in medicines on the Danish market, and many of the reports referred to cases outside the EU/EEA.
sygdomme (nervous system disorders) kommet tilbage på listen igen.
However, nervous system disorders are back on the list.
Der betales ikke årsafgift/kontrolgebyr i det år der betales registreringsgebyr for førstegangsregistreringen.
However, no annual fee/control fee is payable in the year when the registration fee for first-time registration is paid.
Der findes imidlertid ikke sammenligninger af esomeprazol 40 mg med protonpumpehæmmer regimer, hvor dosis er ækvieffektiv.
However, no comparisons exist between esomeprazole 40 mg and proton pump inhibitor regimens in which the dose is equieffective.
Det er dog ikke alle lægepraksissystemer, der stiller den fulde indikationsliste til rådighed.
However, not all medical practice systems make the full indication list available.
Men du skal være opmærksom på, at der er en lille risiko for, at pennen ikke virker.
However, note that there is a low risk that the pen does not work.
Der er dog fortsat work sharing procedurer i gang, som skal afsluttes.
However, ongoing work sharing procedures need to be completed.
Over en længere årrække (2013-2016) kan det dog ses, at antallet af ansøgninger om kliniske lægemiddelforsøg har været stabilt placeret omkring ca. 300 ansøgninger.
However, over a number of years (2013 to 2016), the number of clinical trial applications has remained stable at around 300 applications.
Behandling af personoplysninger af offentlige myndigheder,
However, personal data processed by public authorities under this
Vær dog opmærksom på, at virksomheder, der formidler lægemidler, skal lade sig registrere som formidler.
However, please note that companies acting as a broker of medicinal products must be registered as a broker.
Bemærk dog, at vores bagvedliggende system kun kan håndtere 1.000 karakterer inkl. mellemrum.
However, please note that our back-end system can only handle up to 1,000 characters, including spaces.
Se dog "Retningslinjer for elektroniske ansøgninger" samt "Skift af format" og "Formatkrav" herunder.
However, please see the "Guidelines on submission of electronic applications" as well as the sections "Format switch" and "Format requirements" below.
Ordinerende læge har dog pligt til at sætte sig ind i det lægemiddel, som ordineres.
However, prescribing doctors are obligated to become acquainted with all medicines they prescribe.
Der findes dog kun prisoplysninger for de perioder, hvor lægemidlerne har været markedsført.
However, price information is only available for the periods during which the medicines have been marketed.
Priorix indeholder dog ikke aluminium, hvorfor denne vaccine ikke fremkalder granulomer.
However, Priorix does not contain aluminium and does not induce granulomas.
Det er dog ikke tilladt for privatpersoner at tage medicin til brug for dyr med ind i Danmark eller at bestille det fra udlandet:
However, private individuals are neither allowed to import veterinary medicines into Denmark nor to order it abroad.
Dog må bibeskæftigelsen ikke indebære risiko for interessekonflikt ift. arbejdet i Lægemiddelstyrelsen.
However, secondary employment must not cause a potential conflict of interest with the duties performed for the Danish Medicines Agency.
Flere af stikprøverne viste imidlertid, at indholdet af guld og sølv i tandkronerne var en smule højere end fabrikanterne selv havde angivet.
However, several of the samples showed that the gold and silver contents in the dental crowns were somewhat higher than the contents declared by the manufacturers.
Som ved andre ikke markedsførte lægemidler kræves desuden, at al anden behandling med godkendte lægemidler til den pågældende sygdom har været afprøvet uden tilstrækkelig effekt.
However, single reimbursement can only be granted if all other treatments with authorised medicines intended for the concerned disease have been tried with no sufficient effect.
Dog kan tilfælde hvor en virksomhed erklæres non-GMP have store konsekvenser for de markeder det måtte berøre.
However, situations in which a company is declared non-GMP compliant could have major consequences for the affected markets.
Imidlertid er der enkelte ændringer i hhv. komitéloven og lægemiddelloven, der træder i kraft 1. juli 2016, jf. § 36, stk. 2, i lov nr. 620 af 8. juni 2016.
However, some of the amendments to the Danish Committee Act and the Danish Medicines Act will take effect on 1 July 2016, see section 36(2) of act no. 620 of 8 June 2016.
Standardforskrifter og listen over forsøgsledere kan dog ændres uden godkendelse i Lægemiddelstyrelsen.
However, standard operation procedures and the list of study directors may be changed without the authorisation of the Danish Medicines
Et sådant retsgrundlag eller en sådan lovgivningsmæssig foranstaltning bør
However, such a legal basis or legislative measure should be clear and precise and its
3-årsfristen vil dog først begynde at løbe fra 17. december 2005.
However, the 3-year period only counts from 17 December 2005.
Kommissionen bør inden for en rimelig frist evaluere virkningen af sidstnævnte afgørelser og rapportere
However, the absence of a reaction of the supervisory authority within that period should be
Loven træder dog først i kraft i 2018.
However, the act does not come into force until 2018.
Bivirkningen er dog indtil videre kun vedtaget for pramipexol.
However, the adverse reaction has so far only been adopted for pramipexole.
Formanden og sekretariatet skal dog straks have besked, hvis indsigelserne går på den måde, indholdet af en beslutning er gengivet på.
However, the Chairman and secretariat must be informed immediately if objections are made to the way in which the content of a decision has been presented.
Formanden og sekretariatet skal dog straks have besked, hvis indsigelserne vedrører den måde, indholdet af en beslutning er gengivet på.
However, the Chairman and secretariat must be informed immediately if objections are made to the way in which the content of a decision is presented.
Formanden og sekretariatet skal dog straks have besked, hvis indsigelserne går på den måde, indholdet af en drøftelse er gengivet på.
However, the Chairman and secretariat must be informed immediately if objections are made to the way in which the content of a discussion is presented.
Ved ændringerne i december 2007 af bekendtgørelse om gasser til medicinsk brug er der imidlertid åbnet for en mulighed for at genudlevere en gas, der er returneret fra en bruger.
However, the changes made in December 2007 to the Executive Order on Medical Gases have opened up for the possibility to redispense a gas which has been returned by a different user.
Nævnet kan dog godt træffe beslutning om en sag, selv om det ikke står på dagsordenen, hvis alle medlemmer er enige om at gøre det.
However, the Committee can still make a decision in a case which is not on the agenda if all members agree to do so.
Nævnet finder imidlertid ikke, at de foreslåede ændringer er i modstrid med en afhjælpning af underbehandlingen, da de foreslåede ændringer går hånd i hånd med de gældende behandlingsrekommandationer og er i overensstemmelse med rationel farmakoterapi.
However, the Committee does not find that the proposed amendments go against ameliorating the issue of undertreatment, since the proposed amendments comply with the current treatment recommendations and rational pharmacotherapy.
Virksomheden skal dog meddele til Lægemiddelstyrelsen, hvis denne person ændres, da den kvalitetsansvarlige person er en central nøgleperson i virksomheden og Lægemiddelstyrelsen derfor ønsker at være orienteret.
However, the company must inform the Danish Medicines Agency if the responsible person is replaced because the responsible person is a key person of the company, and the Danish Medicines Agency would like to be informed about such change.
Undersøgelsens konklusioner er imidlertid baseret på resultaterne fra en meget lille del af studierne (12 styk), som kun omfattede 3.000 patienter.
However, the conclusions are based on the results of only 12 trials covering 3,000 patients.
I høringssvarene bruges VALUE-studiet imidlertid til at argumentere for risiko ved skift fra angiotensin-II antagonist til ACE-hæmmer, som man frygter, vil være til stede, hvis velregulerede patienter med hypertension ændrer behandling fra angiotensin-II antagonist til ACE-hæmmer.
However, the consultation responses use the VALUE study to substantiate the risk feared to be present if well-controlled hypertension patients switch from an angiotensin II antagonist to an ACE inhibitor.
Domstolen anfører dog, at sådanne ordninger for at være forenelige med traktaten skal basere sig på objektive kontrollerbare kriterier, som er uafhængige af produkternes oprindelse.
However, the Court notes that in order to be compatible with the treaty, such systems must be based on objective and verifiable criteria without reference to the origin of the products.
Det danske medicintilskudssystem er imidlertid ikke en prisfastsættelses- eller en priskontrolordning men en medicintilskudsordning.
However, the Danish medicinal reimbursement system is not a price fixing system or a price control system, but a medicinal reimbursement system.
Helt generelt finder Lægemiddelstyrelsen dog ikke, at compliance alene kan retfærdiggøre en pris, der væsentligt overstiger summen af priserne for enkeltstofferne (eller hvor relevant: priserne på sammenlignelige analoge billigere enkeltstoffer i ækvieffektive doser) hver for sig.
However, the Danish Medicines Agency does not find in general that compliance alone can justify a price which significantly exceeds the sum of the prices for the individual substances (or where relevant: the prices of less expensive comparable analogue individual substances in equieffective doses).
Det vil dog efter Lægemiddelstyrelsens opfattelse være et fåtal af parallelimportører, der kun foretager mærkning af lægemidlerne.
However, the Danish Medicines Agency finds that only very few parallel importers add labels to medicinal products as the only activity.
Lægemiddelstyrelsen har dog også meddelt fritagelse i visse tilfælde, hvor en enkelt lægemiddelform eller styrke alene fremstilles af hensyn til ganske få patienter (specielt blandt de sygehusspecifikke præparater), som ellers ikke har mulighed for behandling.
However, the Danish Medicines Agency has also granted exemption in special cases where a medicine has only been prepared for very few patients who would otherwise have no treatment options (particularly in the case of hospital products).
Lægemiddelstyrelsen har imidlertid besluttet, at for præparater godkendt gennem DCP, MRP og nationale procedurer kan det accepteres, at der indsendes en notifikation om afregistrering.
However, the Danish Medicines Agency has decided that for products approved under DCP, MRP and national procedures it is acceptable to submit a deregistration notification.
Denne sanktion har Lægemiddelstyrelsen endnu ikke fundet anledning til at anvende over for detailforhandlere.
However, the Danish Medicines Agency has never found cause to impose this sanction on retail distributors.
Lægemiddelstyrelsen er derimod åben for at uddybe og kommentere de spørgsmål, der er stillet i den første assessmentrapport ved telefoniske henvendelser.
However, the Danish Medicines Agency is prepared to elaborate and comment on questions raised in the first assessment report via telephone.
Lægemiddelstyrelsen kan dog være behjælpelig med at udstede autoriserede kopier af GDP-certifikatet, hvis den elektroniske udgave ikke er tilstrækkelig.
However, the Danish Medicines Agency may help to issue authorised copies of the GDP certificate if the electronic version is not adequate.
Lægemiddelstyrelsen kan dog være behjælpelig med at udstede autoriserede kopier af GMP-certifikatet, hvis den elektroniske udgave ikke er tilstrækkelig.
However, the Danish Medicines Agency may help to issue authorised copies of the GMP certificate if the electronic version is not adequate.
Medarbejderne i Lægemiddelstyrelsen har imidlertid adgang til en log over alle aktiviteter i DKMAnet og vil ved tvivlsspørgsmål kunne dokumentere en handling med identifikation af bruger-ID, dato, tidspunkt og handling.
However, the employees of the Danish Medicines Agency have access to an activity log in DKMAnet, and in case of doubt, they will be able to document an action with identification of user ID, date, time and action.
EU-myndigheder vil dog fortsat have et risikobaseret overvågningsprogram og stikprøvevist udføre inspektioner af de konkrete virksomheder.
However, the EU authorities will maintain their risk-based approach and will randomly carry out inspections of specific companies.
De faste, ens priser omfatter dog ikke medicin, der må sælges uden for apotekerne, fx visse typer håndkøbsmedicin og naturlægemidler.
However, the fixed, identical prices do not comprise medicines that are permitted for sale outside pharmacies, e.g. certain types of over-the-counter medicines and natural medicinal products.
Man skal dog være opmærksom på følgende forhold:
However, the following must also be taken into consideration:
Gassen vil derimod være medicinsk udstyr, og skal være CE-mærket.
However, the gas will be considered a medical device, and must therefore be CE marked.
Implementeringen er imidlertid blevet udsat.
However, the implementation has been postponed.
videnskabelig forskning kan personoplysninger behandles til videnskabelige forskningsformål under iagttagelse af
However, the imposition of criminal penalties for infringements of such national rules and of
Der er dog intet til hindring for at både dåsen og den ydre mærkning er forsynet med forsegling.
However, the labelling may also be added to both the can and the outer box.
Der kan dog være regler i lovgivningerne for fødevarer eller kosmetik, som skal opfyldes, for at produkter som f.eks. hampeshampoo og hampeøl med lavt THC-indhold er lovlige at sælge.
However, the law may still impose rules on food or cosmetic products that must be complied with before products like hemp shampoo and hemp beer with a low THC content can be sold legally.
Dog bruges det lineære produkt gadobensyre (Multihance®) i mindre omfang på nuværende tidspunkt i Danmark.
However, the linear product gadobenic acid (Multihance®) is presently used to a lesser degree in Denmark.
Lægemidlerne skal dog have samme legale grundlag (Art.
However, the medicinal products must have the same legal basis (Art.
Lægemidlerne skal dog have samme legale grundlag (Art. 10(1) og 10(3) for humane ansøgninger og Art. 13(1) og 13(3) for veterinære ansøgninger betragtes i den forbindelse som samme legale grundlag).
However, the medicinal products must have the same legal basis (Art. 10(1) and 10(3) for human applications and Art. 13(1) and 13(3) for veterinary applications are considered to be the same legal basis).
Navnet må dog ikke være vildledende eller fremkalde forveksling med andre cannabismellemprodukter eller -slutprodukter eller andre lægemidler i øvrigt.
However, the name should not mislead or cause confusion with other cannabis intermediate products or cannabis products or any other medicinal products.
Den nye analyse af bivirkningsrapporterne viser dog, at Bravecto® i meget sjældne tilfælde kan fremkalde kramper og træthed.
However, the new analysis of the reported adverse events shows that Bravecto® may cause convulsions and fatigue on very rare occasions.
Antallet af indberetninger er imidlertid ikke et komplet udtryk for forekomsten af bivirkninger, da det ikke er alle formodede bivirkninger, der bliver indberettet.
However, the number of ADR reports is not a perfect expression of the occurrence of adverse reactions since not all adverse reactions are reported.
Antallet af ansøgninger i denne gruppe er dog faldet i forhold til 2008, hvilket skyldes, at dipyridamol (Persantin og Persantin Retard) fik generelt tilskud i maj 2008.
However, the number of applications within this group decreased compared to 2008, which can be ascribed to the fact that dipyridamole (Persantin and Persantin Retard) was granted general reimbursement in May 2008.
Antallet af ansøgninger i denne gruppe er dog faldet i forhold til 2007, hvilket formentlig skyldes, at dipyridamol (Persantin og Persantin Retard) fik generelt tilskud i maj 2008.
However, the number of applications within this group decreased on 2007, which may presumably be ascribed to the fact that dipyridamole (Persantin and Persantin Retard) was granted general reimbursement in May 2008.
Antallet af ansøgninger om kliniske lægemiddelforsøg har dog været stabilt med ca. 300 ansøgninger om året siden 2013.
However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.
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.