The European regulatory framework for medicinal products covers authorised cannabis-containing pharmaceutical products. The latter are subject to the general requirements applicable to medicinal products, meaning that the European Union does not have a specific framework for cannabis-derived medicinal products

This report seeks to outline the labelling and packaging requirements that cannabis-containing medicinal products need to comply with when their placing on the European market is authorised.

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Table of contents

  1. Executive summary
  2. Introduction
  3. Overview of the authorisation procedure
  4. Common labelling requirements
  5. Outer packaging
  6. Immediate packaging
  7. Package leaflet
  8. Labelling requirements for medicinal products in the UK
  9. Labelling guidelines for marketing authorisation holders

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“ Labelling requirements for medical cannabis products in the EU and the UK ”

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