Documents - Nomenclature, excipients, abbreviated indications

3 documents on Nomenclature, excipients, abbreviated indications

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  1. MEB 13: Nomenclature of pharmaceutical products

    This document describes the requirements which the marketing authorisation holder has to fulfil when submitting a proposal for a ...

    Policy document | 23-03-2020

  2. MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging

    Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of ...

    Policy document | 10-05-2019

  3. MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use

    Policy document | 11-09-2018