Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product · INTERNATIONAL ORGANISATIONS|United Nations|UN specialised agency|World Health Organisation

    #665598

    IATE #3599449
    an Nós Imeachta um Liostú Úsáide Éigeandála Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Notfallzulassung
    de
    Emergency Use Listing procedure | EUL procedure | emergency use listing process | Emergency Use Assessment and Listing procedure | EUAL procedure
    en
    Definition WHO procedure to assess the suitability of novel health products during public health emergencies to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality Reference "COM-EN, based on:WHO (World Health Organization) > News > WHO validates Sinovac COVID-19 vaccine for emergency use and issues interim policy recommendations (30.9.2021)"
    procédure d’inscription sur la liste d’utilisation d’urgence | protocole OMS d'autorisation d'utilisation d'urgence | autorisation d'utilisation d'urgence au titre du protocole EUL | protocole EUL
    fr
    Definition procédure de l'OMS visant à mettre à disposition le plus rapidement possible des médicaments, des vaccins et des outils de diagnostic pour faire face à une situation d'urgence, tout en respectant des critères stricts d'innocuité, d'efficacité et de qualité Reference "COM-FR d'après le site de l'OMS > Page d'accueil > Communiqués de presse, communiqué de presse du 1er juin 2021, «L’OMS valide le vaccin anti-COVID-19 Sinovac pour une utilisation d’urgence et publie des recommandations provisoires» (13.8.2021)"
  2. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · SOCIAL QUESTIONS|health|pharmaceutical industry

    #688034

    IATE #3639509
    údarú margaíochta éigeandála sealadach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Meastar gurb iomchuí freisin go bhféadfadh an Coimisiún údaraithe margaíochta éigeandála sealadacha a dheonú chun aghaidh a thabhairt ar éigeandálaí sláinte poiblí. Féadfar údaruithe margaíochta éigeandála sealadacha a dheonú ar choinníoll, ag féachaint d’imthosca na héigeandála sláinte poiblí, gur mó an tairbhe a bhainfidh leis an táirge íocshláinte lena mbaineann a bheith le fáil ar an margadh láithreach ná an riosca is gné dhílis den fhéidearthacht go mbeadh breis sonraí ardcháilíochta cuimsitheacha cliniciúla agus neamhchliniciúla fós ag teastáil.' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    befristete Notfallzulassung
    de
    Definition Zulassung für Notlagen im Bereich der öffentlichen Gesundheit, bei denen ein hohes Interesse an der schnellstmöglichen Entwicklung und Zulassung sicherer und wirksamer Arzneimittel besteht Reference "COM-DE gestützt auf die MITTEILUNG DER KOMMISSION AN DAS EUROPÄISCHE PARLAMENT, DEN RAT, DEN EUROPÄISCHEN WIRTSCHAFTS- UND SOZIALAUSSCHUSS UND DEN AUSSCHUSS DER REGIONEN Reform des Arzneimittelrechts und Maßnahmen zur Bekämpfung antimikrobieller Resistenzen"
    temporary emergency marketing authorisation
    en
    Definition "marketing authorisation for medicinal products at EU level for public health emergencies where there is a major interest in developing and authorising safe and effective medicines as quickly as possible" Reference "COM-Terminology Coordination, based on:Communication from the Commission - Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance, COM(2023) 190 final."
    Comment Such authorisations should be granted provided that the benefit of the immediate availability of the medicinal product in question on the market, with regard to the circumstances of the public health emergency, outweighs the risk inherent in the fact that additional comprehensive quality, non-clinical, clinical data may not yet be available (though they should still be required at a later stage).