Gaois

This is a static copy of data that is exported from IATE on an occasional basis. It should not be assumed that information provided about an entry here will always correspond to the current version of the entry in IATE. That current version can be checked by clicking on the link on the upper right hand side of each entry. More information »

1 result

  1. 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"