Gaois

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  1. SOCIAL QUESTIONS|health|health policy|organisation of health care|pharmaceutical legislation · SOCIAL QUESTIONS|health|pharmaceutical industry

    #525723

    IATE #43738
    údarú margaíochta in imthosca eisceachtúla Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'De mhaolú ar Airteagal 5(2), beidh údarú margaíochta in imthosca eisceachtúla bailí ar feadh tréimhse 1 bhliain amháin.' Reference Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA
    Erteilung der Genehmigung für das Inverkehrbringen unter besonderen Bedingungen
    de
    exceptional circumstances Marketing Authorisations | marketing authorisation under exceptional circumstances
    en
    Definition marketing authorisation granted in absence of comprehensive data Reference European Medicines AGency (EMA). 'Conditional marketing authorisation' (9.12.2020)
    Comment The legal basis for the marketing authorisation (MA) under exceptional circumstances is the Article 14 (8) of the Regulation (EC) No 726/2004, and the relevant documentation for applications in exceptional circumstances are laid down in Part II of Annex I of Directive 2001/83/EC, as amended. Products for which the applicant can demonstrate in this application that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because: - the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or - in the present state of scientific knowledge, comprehensive information cannot be provided, or - it would be contrary to generally accepted principles of medical ethics to collect such information, may be eligible for marketing authorisation under exceptional circumstances. Consequently, the authorisation under exceptional circumstances is granted subject to a requirement for the applicant to introduce specific procedures, in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken.