Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #647267

    IATE #3535616
    nós imeachta díláraithe um údarú Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    dezentralisiertes Verfahren | dezentralisiertes Gemeinschafts-Zulassungsverfahren
    de
    decentralised authorisation procedure | decentralised procedure | DCP
    en
    Definition in the European Union, procedure for authorising medicines in more than one European Union Member State in parallel Reference "European Medicines Agency, Glossary (18.5.2020)"
    Comment "It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State.Not to be confused with mutual recognition."
    procédure décentralisée | procédure communautaire d'autorisation décentralisée
    fr
  2. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|pharmaceutical industry

    #682911

    IATE #3535560
    an Grúpa Comhordaithe d'Aitheantas Frithpháirteach agus do Nósanna Imeachta Díláraithe - don Duine Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    CMDh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Koordinierungsgruppe für das Verfahren der gegenseitigen Anerkennung und das dezentralisierte Verfahren - Humanarzneimittel
    de
    Coordination Group for Mutual Recognition and Decentralised Procedures - Human | CMDh | Co-ordination group for Mutual recognition and Decentralised procedures – human
    en
    Definition group set up under Directive 2004/27/EC for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States, in accordance with the mutual recognition procedure or the decentralised procedure Reference "Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance), CELEX:32004L0027; CMDh website, http://www.hma.eu/cmdh.html [12/02/2020]"
    Comment The Group's tasks were substantially extended as of 2012 under Directive 2010/84/EU, amending Directive 2001/83/EC as regards pharmacovigilance.
    Groupe de coordination pour la procédure de reconnaissance mutuelle et la procédure décentralisée - médicaments à usage humain
    fr