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What’s really needed on a European clinical label?

Find out if your text is in compliance with Annex 13

  • This guide walks US-based clinical supply professionals through the EU GMP Annex 13 labeling requirements.
  • Articles 26-33 are reviewed and broken down into plain and simple English with label text examples.
  • This guide will explore all Annex 13 labeling requirements including:
  • What are the minimal labeling requirements when primary and secondary packaging are to remain together?
  • What information is critical to include on small primary packages (i.e. ampoules)?


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