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Tag Archives: centralised procedure

EMA’s pre-authorisation procedural advice for the centralised procedure updated

The European Medicines Agency (“EMA”) has published an updated version of the guidance document on pre-authorisation for users of the centralised procedure. The update relates to a new question concerning the preparation of the dossier. Background The EMA’s guidance document helps applicants for marketing authorisations in the European Union (“EU”) to prepare correct and timely