natgillin/translations-raw huggingface dataset:
Hvilke hyppige/vigtige afvigelser har der været ved inspektion af emnet ”organisation og personale”?
The qualified person responsible for pharmacovigilance (QPPV) is not adequately qualified and/or has insufficient overview
Kvalitetskravene sikrer, at naturlægemidler er fremstillet af veldefinerede råvarer, og at produktet opfylder krav til ensartethed og holdbarhed.
The quality criteria ensure that natural medicinal products are manufactured from well defined raw materials and that the product satisfies requirements for homogeneity and durability.
Kvaliteten vurderes løbende via DANAK-akkrediteringerne og gennem de fælleseuropæiske auditprogrammer, Mutual Joint Audits (MJA), der dækker laboratorieområdet, Joint Audit Programme (JAP), der dækker inspektionsområdet, og BEMA, der dækker hele vores myndighedsvaretagelse.
The quality is assessed on an ongoing basis via DANAK accreditations and through the common European audit programmes, Mutual Joint Audits (MJA), covering the laboratory area, the Joint Audit Programme (JAP), covering the inspection area, and BEMA, covering our entire regulatory responsibilities.
Kvalitetschefen er formand for Kvalitetskomiteen og refererer til vicedirektøren.
The Quality Manager is chairman of the Quality Committee and reports to the Deputy Director General.
Kvalitetshåndbogen skal beskrive procedurer og instruktioner for de anvendte processer.
The quality manual should describe the procedures and instructions for the applied processes.
kvaliteten eller sikkerheden ved ethvert forsøgslægemiddel der anvendes i forsøget,
the quality or safety of the investigational medicinal products used in the trial,
Den kvalitetsansvarlige angives ikke på den udstedte engrosforhandlertilladelse, men da oplysningen er en del af de informationer, der ligger til grund for udstedelse af en engrosforhandlertilladelse, skal Lægemiddelstyrelsens informeres skriftligt ved skift af kvalitetsansvarlig person.
The quality responsible person is not stated on the issued wholesale dealer's authorisation, but since the information forms part of the information forming the basis for the issuance of a wholesale dealer's authorisation, the Danish Health and Medicines Authority must be informed in writing in case of change of the quality responsible person.
Den ansvarlige person skal have sin vante gang i virksomheden i et tilstrækkeligt omfang under hensyntagen til virksomhedens aktiviteter.
The quality responsible person must be at the company regularly to an adequate extent with due consideration to the company's activities.
Kvalitetsstrategiens kontekst og afsæt
The quality strategy - context and background
Kvalitetsstrategien bidrager til dette arbejde.
The quality strategy contributes to this work.
Kvalitetssystemet skal som minimum omfatte følgende emner:
The quality system must as a minimum encompass the following:
De anførte mængder er pr
The quantities stated are per
Mængden af aktiv bestanddel og samtlige hjælpestoffer skal ligeledes fremgå.
The quantity of the active substance and all excipients must also appear.
Mængden af aktivt indholdsstof/aktiv markør angives som den eksakte mængde i standardiserede droger/drogetilberedninger (aktivt indholdsstof) og som interval for kvantificerede droger/drogetilberedninger (aktiv markør).
The quantity of the active substance/active marker should be indicated as the exact quantity in standardised herbal substances/herbal preparations (active substance) and as an interval for quantified herbal substances/herbal preparations (active marker).
Mængden skal anføres i gram eller milligram pr doseringsenhed, hvis der er tale om en doseringslignende formulering.
The quantity should be expressed in grams or milligrams per dosage unit in case of a dosage formulation.
Spørgsmålet blev prøvet i Ministeriet for Sundhed og Forebyggelses afgørelse i Servier Danmark A/S' klage over Lægemiddelstyrelsens afgørelse af den 16. januar 2009.
The question was examined by the Danish Ministry of Health and Prevention in its decision concerning Servier Danmark A/S's complaint about the Agency's decision of 16 January 2009.
Quick guide giver en introduktion til DKMAnet samt overblik over hvilken funktion du skal vælge, når du har materiale du ønsker at indsende via DKMAnet Quick Guide til kliniske forsøg og DKMAnet
The quick guide gives you an introduction to DKMAnet and an overview of which functions to use when you want to submit documentation via DKMAnet Quick guide to clinical trials and DKMAnet
Den radioaktive stråling gør det muligt at "fotografere" lægemidlets vej gennem kroppen.
The radiation from the radiopharmaceutical makes it possible to photograph and trace the products path through the body.
Listen over håndkøbslægemidler, som i begrænset mængde indholdsstof har udleveringsbestemmelse HX eller HX18, er senest opdateret i september 2013.
The range of OTC medicines, which in limited content of active substance falll under dispensing group HX or HX18, was last updated in September 2013.
Systemet omfatter lande både inden- og udenfor EU/EØS, og muliggør deslige at Danmark selv kan udmelde produktfejl.
The Rapid Alert System covers countries in and outside the EU/EEA and enables Denmark to send out notifications about observed product defects.
Rapid Alert systemet omfatter udelukkende lægemidler i den legale distributionskæde.
The Rapid Alert System covers medicinal products in the legal supply chain only.
Rapid Alert systemet omfatter udelukkende lægemidler i den legale distributionskæde.
The Rapid Alert System covers medicines in the legal supply chain only.
Via rapid alert systemet har vi set et stigende antal advarsler om forfalskede lægemidler i det legale distributions netværk i perioden 2003-2006, jf. tabel 1.
The Rapid Alert System has reported an increasing number of warnings about counterfeit medicinal products in the legitimate supply chain in the period 2003-2006, cf. table 1.
Via "rapid alert" systemet er der modtaget et stigende antal advarsler om forfalskede lægemidler i det legale distributionsnetværk i perioden 2003-2007, jf. tabel 1.
The Rapid Alert System reported an increasing number of warnings about counterfeit medicinal products in the legitimate supply chain in the period 2003-2007, cf. table 1.
Den procentsats, der står på bevillingen, er forældet.
The rate written on the licence no longer applies.
Ved bedømmelsen ”Ikke acceptabel” og i visse tilfælde ved bedømmelsen ”Ikke tilfredsstillende” beder Lægemiddelstyrelsen detailhandleren om en skriftlig tilbagemelding og eventuel fremsendelse af dokumentation for, at de fundne afvigelser er bragt i orden.
The rating ‘Unacceptable' and in some cases the rating ‘Unsatisfactory' means that the Danish Medicines Agency will ask the retail distributor to submit a written report possibly with the inclusion of documentation to prove that the deficiencies identified have been corrected.
Baggrund for sammensætning af faggrupper/interesser i nævnet
The rationale behind composition of professional groups/interests
Baggrunden for sammensætningen af faggrupper/interesser i nævnet
The rationale behind the Committee's composition of professional groups/interests
Revurderingen indbefatter en vurdering af, om de lægemidler der har generelt tilskud fortsat opfylder disse kriterier, og om lægemidler uden generelt tilskud fortsat ikke opfylder disse kriterier.
The re-assessment includes an assessment of whether the medicinal products that currently qualify for general reimbursement continue to meet these criteria and whether medicinal products not subject to general reimbursement continue not to meet these criteria.
Reaktorerne danner ved bestråling stabile isotoper til terapeutisk anvendelse og Mo99/Tc99.
The reactors provide irradiation for activation of stable isotopes for therapy and for Mo99/Tc99.
Når vi så hurtigt efter tilskudsændringen i juni 2009 atter har vurderet tilskud for nogle af de samme lægemidler, skyldes det, at forudsætningerne har ændret sig.
The reason for having reassessed the reimbursement for some of the same medicinal products so quickly after the reimbursement change in June 2009 is that the preconditions have changed.
Afslagene er typisk begrundet i, at det ikke er dokumenteret tilstrækkeligt i ansøgningen, at patienten ikke kan behandles med billigere og lige så effektive lægemidler med generelt tilskud.
The reason for refusal is usually that it has not been documented sufficiently in the application that the patient cannot be treated with less expensive and just as efficient medicines with general reimbursement.
Afslagsbegrundelsen er typisk, at det ikke er dokumenteret tilstrækkeligt i ansøgningen, at patienten ikke kan behandles med billigere og lige så effektive lægemidler med generelt tilskud.
The reason for refusal is usually that it has not been documented sufficiently in the application that the patient cannot be treated with less expensive and just as efficient medicines with general reimbursement.
Begrundelse for justeringen er, at det ved behandling af reklamationer og bivirkninger hos originalfremstilleren er vigtigt, at denne kan få oplyst eller se ”råvarebatchnummeret”, hvis der modtages en reklamationspakning.
The reason for the changed practice is that when the manufacturer of the original product assesses complaints and adverse reactions, it is important that the manufacturer can be informed of or see the ‘raw material batch number' if the manufacturer receives a complaints package.
Begrundelsen for anbefalingen er, at Lægemiddelstyrelsen i en række tilfælde ikke har været orienteret om de foretagne variationer om ændringer af indehaver af markedsføringstilladelsen og/eller af repræsentanten.
The reason for the recommendation is that there has been a number of cases where the Danish Medicines Agency was not informed of variations regarding change of the marketing authorisation holder and/or representative.
Begrundelsen for indstillingen var, at prisen på clopidogrel nu efter nævnets vurdering står i rimeligt forhold til dets behandlingsmæssige værdi, når behandlingen stilles over for behandling med acetylsalicylsyre (og evt. dipyridamol).
The reason for the recommendation was that the Committee found the price of clopidogrel to be commensurate with its therapeutic value when compared to treatment with acetylsalicylic acid (and possibly dipyridamole).
Årsagen til suspenderingen er, at Lægemiddelstyrelsen på en inspektion den 13. december 2016 har konstateret en række lovovertrædelser i virksomheden, der viser, at virksomheden ikke i tilstrækkeligt omfang overholder GMP-reglerne for fremstilling af lægemidler.
The reason for the suspension is that on its inspection on 13 December 2016 the Danish Medicines Agency found a number of non-compliance issues, which show that the company does not comply with the GMP rules on the manufacturing of medicinal products to an adequate extent.
Årsagen er, at der er risiko for at auto-injektoren ikke virker.
The reason for the withdrawal is that there is a risk that the auto-injector does not work.
Årsagen til dette skyldes mange kemiske variationer og prioritering af øvrige godkendelsesprocedurer.
The reason for this is due to many chemical variations and prioritization of other approval procedures.
Årsagen til dette skyldes modtagelse af mange kemiske variationer og nødvendigheden af prioritering af øvrige godkendelsesprocedurer.
The reason for this is due to the receipt of many chemical variations and the need to prioritize other approval procedures.
Dette er gjort ud fra en vurdering af, at det især i disse tilfælde er muligt at sætte ind og reducere antallet af fejl.
The reason for this is that in these cases in particular, it is possible to make an effort to reduce the number of defects.
Baggrunden herfor er, at antallet af modtagne nye national ansøgninger er steget med 29 % i 2014, i forhold til 2013.
The reason for this is that the number of new national applications increased by 29% in 2014, compared to 2013.
Baggrunden er, at vi ønsker, at der tages aktivt stilling til hvilke spørgsmål, der skal videresendes til indberetter.
The reason for this is that we would like you to actively decide which questions should be forwarded to the reporter.
Dette skyldes, at en engrosforhandler kun må opbevare lægemidler, som er frigivet til EU/EØS-markedet.
The reason is that a wholesale distributor can only store medicines released for the EU/EEA market.
Baggrunden er, at EMA kun tillader, at en aktivitet overføres én gang pr. site
The reason is that EMA only allows to transfer an activity once per site.
Ud over at det er ulovligt at besidde cannabis, er baggrunden, at brug af cannabis medfører en betydelig risiko for alvorlige bivirkninger.
The reason is that it is illegal to possess cannabis and the use of cannabis involves a significant risk of serious side effects.
Dette skyldes, at lægemidler, som sælges af en virksomhed fra et tredjeland, skal frigives til EU/EØSmarkedet, efter at ejerskabet er overgået til EU/EØS-virksomheden.
The reason is that medicines sold by a company from a third country must be released for the EU/EEA market after the ownership has been passed to the EU/EEA company.
Det skyldes bl.a., at POTS er en relativt ny diagnose, hvor symptombilledet varierer.
The reason is that POTS is a relatively new diagnosis with varying symptoms.
Nogle apoteker indberetter nemlig til CTR allerede ved prisberegningen.
The reason is that some pharmacies report to the CTR register already when they calculate the price.
Nogle apoteker indberetter nemlig først til CTR, når medicinen udleveres.
The reason is that some pharmacies wait until they dispense the medicine before they report it to the CTR register.
Dette skyldes at ansøgningerne overholder tidsfristen i opstartsfasen.
The reason is that the applications meet the deadline in the start-up phase.
Det skyldes, at Sundhedsstyrelsen og Komitésystemet håndterer ændringerne forskelligt.
The reason is that the DHMA and the Scientific Ethical Committee System handle amendments differently.
Det skyldes, at informationen i Artikel 57 databasen er linket til PSUR Repository.
The reason is that the information in the Article 57 database is linked to the PSUR Repository.
Det skyldes, at antallet af kliniske forsøg koordineret fra Region Hovedstaden i 2015 ikke er steget væsentligt i forhold til 2014, på trods af det øgede antal kliniske forsøg.
The reason is that the number of clinical trials coordinated by the Capital Region of Denmark in 2015 did not increase significantly compared with 2014, despite the higher number of clinical trials.
Årsagen hertil er bl.a., at der kun er én markedsføringstilladelse, og det er den som pakningsmaterialet mv. skal afspejle.
The reason is that there is only one marketing authorisation, and this authorisation must be reflected in the packaging material etc.
Baggrunden er, at vi ønsker at bibeholde ens overskrifter i alle de danske produktresumeer og at fastholde vores langvarige praksis med at anføre eksempelvis D.sp.nr. samt Udleveringsgruppe i produktresumeet.
The reason is that we want to have identical headings in all Danish summaries of product characteristics and maintain our long-term practice of stating the D.Sp.No. as well as the dispensing group in the summary of product characteristics.
Årsagen er bl.a. frygten for bakterieresistens blandt dyr og mennesker, samt hensynet til fødevaresikkerheden, idet medicin tiltænkt kæledyr også kan anvendes til fødevareproducerende dyr.
The reason is the fear of bacterial resistance among animals and humans as well as the consideration for food safety since medicines intended for pets may also be used for food-producing animals.
Men det er måske fordi markedet endnu er meget nyt, og der er stadig er så få CE-mærkede apps, som kan karakteriseres som medicinsk udstyr.
The reason may be that the market is still very new and only a few CE marked apps are classified as medical devices.
Det kan evt. skyldes, at lægemidlerne er godkendt på baggrund af forskellige dossierer og dermed har opnået forskellige anvendelsesområder.
The reason may be that the medicinal products are authorised on the basis of different dossiers and have been approved for different indication areas.
Det kan skyldes, at den ikke er blevet overført til databasen, af den nationale myndighed, som har udstedt den.
The reason may be that the national regulatory authority which issued the authorisation has not yet uploaded it to the database.
Forklaringen på, at antallet af ansøgninger er faldet yderligere sammenlignet med 2009, kan være, at:
The reason that the number of applications has dropped even further compared to 2009 could be that
Forklaringen på, at antallet af ansøgninger er faldet yderligere sammenlignet med 2008, kan være, at:
The reason that the number of applications has dropped even further compared with 2008 could be that
En forklaring på, at antallet af ansøgninger er faldet yderligere sammenlignet med 2007, kan være, at de synonyme præparater til bisfosfonater, der er kommet på markedet de seneste år, fortsat er i en prisklasse, hvor prisen ikke er en hindring for, at patienten køber præparatet uden at have en bevilling af tilskud.
The reason that the number of applications has dropped further compared with 2007 could be that the generic products to bisphosphonates having entered the market over the recent years are still within a price range that does not prevent the patient from buying the product without reimbursement.
begrundelse for ansøgningen
the reason why exemption is requested
Når Lægemiddelstyrelsen ikke finder, at der er grundlag for at klausulere det generelle tilskud til de dyre ACE-hæmmere, skyldes det, at klasseeffekten inden for denne gruppe er så omfattende, at det er meget lidt sandsynligt, at en patient ikke vil kunne behandles med en af de billigere ACE-hæmmere.
The reason why the Danish Medicines Agency does not find that there is basis for making the general reimbursement for the expensive ACE inhibitors conditional is that the class effect within this group is so comprehensive that it is very unlikely that a patient should not be eligible for treatment with one of the less expensive ACE inhibitors.
Når tilskuddet til angiotensin-II antagonisterne fjernes, skyldes det, at klasseeffekten inden for denne gruppe er så omfattende, at langt de fleste patienter vil kunne behandles med det billigere generelt tilskudsberettigede losartan eller evt. med en af de ACE-hæmmere, som har generelt tilskud.
The reason why the reimbursement for the angiotensin II antagonists is eliminated is that the class effect within this group is so comprehensive that most patients can be treated with the less expensive losartan, which is eligible for reimbursement, or possibly with one of the ACE inhibitors which are eligible for general reimbursement.
EudraCT-hjemmesiden gemmer nemlig ingen data, men virker kun som et redigeringsværktøj.
The reason you need to do this is because the EudraCT website does not store any data, but merely serves as an editing tool.
Det skyldes, at databasen kun indeholder formodede bivirkninger, at den ikke indeholder oplysninger om, hvor mange der har taget medicinen uden at opleve bivirkninger, og at det ikke er alle formodede bivirkninger, der bliver indberettet.
The reasons are that the database only contains information about suspected adverse reactions, that it does not contain information about how many people have taken the medicine without experiencing adverse reactions and that not all suspected adverse reactions are reported.
Det skyldes blandt andet, at der kun findes meget begrænset information om, hvor mange der har taget en bestemt type medicin uden at opleve en bivirkning, og at det ikke er alle formodede bivirkninger, der bliver indberettet til Lægemiddelstyrelsen.
The reasons are that there is limited information about how many people have taken a particular type of medicine without experiencing an adverse reaction and that not all suspected adverse reactions are reported to the Danish Medicines Agency.
Indstillingen er nærmere begrundet i afsnittet om nævnets synspunkter og begrundelser i relation til lægemidler i ATC-gruppe C09 (ACE-hæmmere, angiotensin-II antagonister og renin-hæmmere).
The reasons for the recommendations are stated in the section on the Committee's viewpoints and reasons in relation to medicinal products in ATC group C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).
Revurderingen har til formål at vurdere, om de forudsætninger, der lå til grund for den oprindelige afgørelse om meddelelse eller ikke-meddelelse af generelt tilskud, herunder generelt klausuleret tilskud, fortsat har gyldighed.
The reassessment aims at assessing whether the assumptions underlying the original decision on granting or not granting general, including restricted, reimbursement, are still valid.
Revurderingen af lægemidler i ATC-gruppe C02 omfatter ikke lægemidler indeholdende doxazosin (C02CA04).
The reassessment of medicinal products in ATC group C02 does not comprise medicinal products containing doxazosin (C02CA04).
Revurderingen af lægemidlers tilskudsstatus skal ses i lyset heraf.
The reassessment of the reimbursement status of medicinal products must be seen in this light.
Med sundhedsloven videreføres reglerne for revurdering uændret.
The reassessment rules remain unchanged under the Health Care Act.
Modtagekontrollen er også en vigtig aktivitet for at undgå forfalskede lægemidler, hvorfor det er vigtigt, at virksomheden har fokus på ID-kontrol, visuel kontrol og relevant analyse bl.
The receipt control function is also an important element in combatting falsified medicinal products, and companies should thus attach importance to ID control, visual control and relevant checks of e.g. the packaging material.
Modtagekontrollen er også en vigtig aktivitet for at undgå forfalskede lægemidler, hvorfor det er vigtigt, at virksomheden har fokus på ID-kontrol, visuel kontrol og relevant analyse bl.a. af pakningsmaterialet.
The receipt control function is also an important element in combatting falsified medicinal products, and companies should thus attach importance to ID control, visual control and relevant checks of e.g. the packaging material.
Receipt date på den nye version af sagen vil være dato for modtagelsen af mail med argumentation fra MAH.
The receipt date of the new version of the case will be the date of receipt of the email with arguments from the MAH.
Apoteket kan mod et mindre gebyr udskrive en liste over, hvad der står om dig i CTR.
The receipt that you receive at the pharmacy displays your balance before purchase.
I kvitteringen fra Lægemiddelstyrelsen modtages et registreringsnummer.
The receipt will include a registration number.
I indstillingen er der en liste med links til de referencer, Medicintilskudsnævnet har lagt vægt på i sin indstilling.
The recommendation contains a list of links to the references which the Reimbursement Committee has emphasised in its recommendation.
I indstillingen findes en liste med links til de referencer, Medicintilskudsnævnet har lagt vægt på i sin indstilling.
The recommendation contains a list of links to the references which the Reimbursement Committee has emphasised in its recommendation.
I indstillingen findes links til de referencer, Medicintilskudsnævnet har lagt vægt på i sin indstilling.
The recommendation contains links to the references which the Reimbursement Committee has emphasised in its recommendation.
Suspenderingen anbefales, efter at alvorlige bivirkninger er indberettet i tilslutning til anvendelse af Velactis.
The recommendation follows reports of serious adverse events after treatment with Velactis.
Indstillingen har været i høring hos virksomheder, der per den 13. januar 2008 havde anmeldt en pris til Lægemiddelstyrelsen på et eller flere lægemidler godkendt til markedsføring i en eller flere af ovennævnte ATC-grupper C02, C03, C07, C08 og C09.
The recommendation has been submitted for consultation with all companies that as of 13 January 2008 had submitted a price to the Danish Medicines Agency for one or more medicinal products authorised for marketing in one or more of the above mentioned ATC groups C02, C03, C07, C08 and C09.