Documents - Duplex marketing authorisation

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  1. MEB 16: Duplex marketing authorisation

    A duplex marketing authorisation is a marketing authorisation for a product of which the dossier is identical to that of a ...

    Policy document | 10-03-2021

  2. Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)

    Directive | 18-06-2018

  3. Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions

    Directive | 18-06-2018

  4. Declaration accompanying a duplex marketing authorisation regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use

    Directive | 01-09-2015