Gaois

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6 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #682053

    IATE #3503253
    Máistirchomhad maidir le Substaintí Gníomhacha Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Le haghaidh substaint ghníomhach, féadfaidh monaróir na substainte gníomhaí nó an t-iarratasóir a shocrú go gcuirfidh monaróir na substainte gníomhaí an fhaisnéis seo a leanas ar fáil i ndoiciméad ar leithligh go díreach do na húdaráis inniúla mar Mháistirchomhad maidir le Substaintí Gníomhacha: (a) tuairisc mhionsonraithe ar an bpróiseas monaraíochta; (b) tuairisc ar an rialú cáilíochta le linn na monaraíochta; (c) tuairisc ar an bpróiseas bailíochtaithe.' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    Máistirchomhad Substainte Gníomhaí Reference "Rialachán Cur Chun Feidhme (AE) 2021/17 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0017/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    ASMF Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Beidh sealbhóir ASMF ionchorpraithe cheana féin i gcórais TF an Aontais lena ndéantar sonraí eagraíochtúla a stóráil agus a sholáthar.' Reference "Rialachán Cur Chun Feidhme (AE) 2021/17 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0017/GA"
    Wirkstoff-Stammdokumentation | Wirkstoff-Stammdatei | ASMF
    de
    Definition beliebtes Instrumentarium für den Wirkstoffhersteller, um seine Informationen vertraulich und nur der Behörde gegenüber zu veröffentlichen Reference COM-DE, gestützt auf: Gengenbach, R., Gengenbach, R.J., Eckert, H.G. & Hähnel, W. (2008). GMP-Qualifizierung und Validierung von Wirkstoffanlagen: ein Leitfaden für die Praxis. 1. Aufl. Weinheim, Bergstr: WILEY-VCH. S. 66.
    Active Substance Master File | ASMF | Drug Master File | DMF | European Drug Master File | EDMF
    en
    Definition document that contains a detailed description of the manufacturing process, quality control during manufacture and process validation prepared in a separate document by the manufacturer of the active substance Reference "Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192"
    Comment A “master file” is a document that contains a detailed description of the manufacturing process, quality control during manufacture and process validation prepared in a separate document by the manufacturer of the active substance. An “active substance master file” is such a document concerning an active substance. An “additional quality master file” is such a document concerning active substances other than chemical active substances, or on other substances present or used in the manufacture of a medicinal product, like excipients
    dossier permanent de la substance active
    fr
    Definition document contenant une description détaillée du procédé de fabrication, du contrôle de la qualité pendant la fabrication et de la validation du procédé, établi sous forme de document distinct par le fabricant de la substance active Reference "Proposition de DIRECTIVE DU PARLEMENT EUROPÉEN ET DU CONSEIL instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE, COM(2023) 192"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688153

    IATE #3639784
    deimhniú máistirchomhaid maidir le substaintí gníomhacha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Bescheinigung über die Wirkstoff-Stammdokumentation
    de
    active substance master file certificate
    en
    Definition certificate granted by the European Medicines Agency (EMA) in accordance with Article 25 of Directive xxx in cases where the relevant data on the active substance concerned are not already covered by a monograph of the European Pharmacopoeia and which can be used instead of submitting the relevant data on a chemical active substance of a medicinal product required in accordance with Annex II to this Directive Reference "COM-Terminology Coordination, based on:Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192"
    Comment The active substance master file certificate shall cover all the information required in Annex II on the active substance
    certificat du dossier permanent de la substance active
    fr
    Definition certificat délivré par l’Agence conformément à l'article 25 de la directive xxx dans les cas où les données pertinentes sur la substance active concernée ne sont pas déjà couvertes par une monographie de la Pharmacopée européenne et sur lequel peuvent s'appuyer les demandeurs d’autorisations de mise sur le marché, au lieu de fournir les données pertinentes sur une substance chimique active d’un médicament requises conformément à l’annexe II Reference "COM-FR d'après: Proposition de directive du Parlement européen et du Conseil instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE, COM(2023) 192"
  3. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #688241

    IATE #3639968
    máistirchomhad breise cáilíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... máistirchomhaid bhreise cháilíochta dá bhféadfaí deimhniú a úsáid chun faisnéis shonrach a chur ar fáil maidir le cáilíocht substainte atá i láthair nó a úsáidtear i monarú táirge íocshláinte ...' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    zusätzliche Qualitäts-Stammdokumentation
    de
    additional quality master file
    en
    Definition master file on an active substance other than a chemical active substance or on other substances present or used in the manufacture of a medicinal product Reference European Commission. DG SANTE. Correspondence dated 16.6.2023
    Comment "'Active substance master file' is only on chemical active substances (Article 25), but in addition to that, the marketing authorisation dossier may rely on an additional quality master file."
    dossier permanent de la qualité supplémentaire
    fr
    Definition dossier permanent relatif à une substance active autre qu'une substance active chimique ou à d'autres substances présentes ou utilisées dans la fabrication d'un médicament Reference COM-FR d'après:correspondance avec les experts de la DG SANTE, Commission européenne
  4. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #664726

    IATE #3592685
    Máistirchomhad Teicneolaíochta Ardáin Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Tráth a chuirtear isteach an chéad sainchomhad (iomlán) bunaithe ar an teicneolaíocht ardáin, féadfaidh an t-iarratasóir “Máistirchomhad Teicneolaíochta Ardáin” a chur isteach i gcomhthráth lena gcuimsítear na sonraí go léir a bhaineann leis an ardán a bhfuil cinnteacht eolaíoch réasúnta ann ina leith go bhfanfaidh sé gan athrú gan beann ar an antaigin/na hantaiginí nó an ghéin/na géinte spéise a chuirtear leis an ardán.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
    Plattformtechnologie-Stammdokumentation
    de
    Platform Technology Master File | vaccine platform technology master file | vPTMF
    en
    Definition file with all data relative to the platform for which there is reasonable scientific certainty that will remain unchanged regardless of the antigen(s)/gene(s) of interest added to the platform that an applicant may submit together with the first (full) dossier based on the platform technology that must be submitted for the marketing authorisation Reference "COM-Terminology Coordination, based on: Delegated Regulation (EU) 2021/805 amending Annex II to Regulation (EU) 2019/6"
    Comment The nature of the data to be included in the Platform Technology Master File will depend on the type of platform. Once a Platform Technology Master File is certified, the certificate may be used to fulfil the relevant data requirements in subsequent applications for marketing authorisations based on the same platform and intended for the same target species.
    dossier permanent de la technologie de plateforme
    fr
    Definition dossier comprenant toutes les données relatives à une plateforme vaccinale pour lesquelles il existe une certitude scientifique raisonnable qu’elles demeureront inchangées quels que soient les antigènes/gènes d’intérêt ajoutés à la plateforme, qu'un demandeur peut présenter parallèlement au dossier complet qui doit être soumis pour le premier produit fondé sur la technologie de plateforme en vue de l'autorisation de mise sur le marché Reference COM-FR, d'après COM-Document interne, SANTE-2020-80966
    Comment La nature des données à inclure dans le dossier permanent de la technologie de plateforme dépendra du type de plateforme.Une fois qu’un dossier permanent de la technologie de plateforme est certifié, le certificat peut être utilisé pour satisfaire aux exigences en matière de données dans les demandes d’autorisation de mise sur le marché ultérieures fondées sur la même plateforme et concernant les mêmes espèces de destination.
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #682214

    IATE #3510053
    Máistirchomhad Antaiginí Vacsaíne Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'I gcás táirgí íocshláinte tréidliachta imdhíoneolaíocha áirithe agus de mhaolú ar fhorálacha Theideal II, Cuid 2, Roinn C de shubstaintí gníomhacha, déantar coincheap na Máistirchomhad Antaiginí Vacsaíne a thabhairt isteach.' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    MCAV Reference Téarmeolaithe COM-GA
    ga
    Definition cuid saorsheasaimh den sainchomhad iarratais ar údarú margaíochta do vacsaín, ina bhfuil an fhaisnéis ábhartha cháilíochta uile maidir le gach ceann de na substaintí gníomhacha atá ina chuid den táirge íocshláinte tréidliachta sin Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    Vaccine Antigen Master File | VAMF | VAMFs
    en
    Definition stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information of biological, pharmaceutical and chemical nature concerning each of the active substances which are part of this medicinal product Reference "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use"
    Comment One given VAMF contains all relevant information of biological, pharmaceutical and chemical nature for one given vaccine antigen, which is common to several vaccines from the same MA applicant or MAH
    Dossier Permanent de l'Antigène Vaccinant | DPAV
    fr
    Definition une partie autonome du dossier de demande d'autorisation de mise sur le marché d'un vaccin, qui contient toute l'information pertinente de nature biologique, pharmaceutique et chimique concernant chacune des substances actives composant ce médicament. La partie autonome peut être commune à un ou plusieurs vaccins monovalents et/ou combinés présenté(s) par le même demandeur ou titulaire d'autorisation de mise sur le marché. Reference "Directive 2003/63/CE de la Commission, du 25 juin 2003, modifiant la directive 2001/83/CE du Parlement européen et du Conseil instituant un code communautaire relatif aux médicaments à usage humain CELEX:32003L0063 & CELEX:02001L0083"
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #681995

    IATE #3500728
    máistirchomhad chóras an fhaireachais cógas Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE (Téacs atá ábhartha maidir le LEE), CELEX:32019R0006/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    máistirchomhad córas faireachas cógas Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    máistirchomhad sa chóras faireachais cógas Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE (Téacs atá ábhartha maidir le LEE), CELEX:32019R0006/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    máistirchomhad an chórais faireachais cógas Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Tar éis don chóras a bhfuil tuairisc air i máistirchomhad an chórais faireachais cógas a bheith foirceanta go foirmiúil, coimeádfaidh sealbhóirí an údaraithe margaíochta leagan leictreonach de go ceann 5 bliana.' Reference "Rialachán Cur Chun Feidhme (AE) 2021/1281 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le dea-chleachtas faireachais cógas agus maidir le formáid, ábhar agus achoimre ar mháistirchomhad an chórais faireachais cógas le haghaidh táirgí íocshláinte tréidliachta (Téacs atá ábhartha maidir le LEE), CELEX:32021R1281/GA"
    Definition tuairisc mhionsonraithe ar chóras an fhaireachais cógas a úsáideann sealbhóir an údaraithe margaíochta i ndáil le táirge íocshláinte tréidliachta údaraithe amháin nó níos mó Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE (Téacs atá ábhartha maidir le LEE), CELEX:32019R0006/GA"
    Pharmakovigilanz-Stammdokumentation (Pharmakovigilanz-Master-File) | Pharmakovigilanz-Stammdokumentation
    de
    Definition detaillierte Beschreibung des Systems der Pharmakovigilanz, das der Inhaber der Genehmigung für das Inverkehrbringen auf eines oder mehrere genehmigte Arzneimittel anwendet Reference "Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel, Konsolidierte Fassung, Art.1 Nr.28e CELEX:02001L0083-20121116/DE"
    pharmacovigilance system master file
    en
    Definition detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products Reference "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use"
    dossier permanent de système de pharmacovigilance
    fr
    Definition description détaillée du système de pharmacovigilance utilisé par le titulaire de l’autorisation de mise sur le marché concernant un ou plusieurs médicaments autorisés Reference COM-Document interne: ENTR/2008/80076/02/02