Gaois

Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry · SOCIAL QUESTIONS|health|health policy|organisation of health care|pharmaceutical legislation
    údarú margaíochta in imthosca eisceachtúla Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'De mhaolú ar Airteagal 5(2), beidh údarú margaíochta in imthosca eisceachtúla bailí ar feadh tréimhse 1 bhliain amháin.' Tagairt "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
    marketing authorisation under exceptional circumstances | exceptional circumstances Marketing Authorisations
    en
    Sainmhíniú marketing authorisation granted in absence of comprehensive data Tagairt "European Medicines AGency (EMA). 'Conditional marketing authorisation' (9.12.2020)"
    Nóta 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.