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- W2891653243 abstract "In 1994, regulations in France allowed some medicines to be marketed before a marketing autorisation was issued: a certificate had to be issued by the French health products agency and was called ATU (temporary use certificate, autorisation temporaire d'utilisation). However, three conditions need to be fulfilled: - serious or rare diseases, - without alternate drug therapy, - positive risk benefit ratio. The French health products agency states after an internal and external expertise is performed, based on drug pharmaceutical quality and efficacy/security report. Eight years later, roles and remarks of different actors (agency, hospital pharmacists and physicians) are described." @default.
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- W2891653243 date "2003-02-12" @default.
- W2891653243 modified "2023-09-27" @default.
- W2891653243 title "Drugs under temporary use certificate: from theory to practice" @default.
- W2891653243 hasPublicationYear "2003" @default.
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