Sherpa Guide EU Annex 13 Labeling

Content Summary

The purpose of this guide is to walk US-based clinical supply professionals through the labeling requirements laid out in Annex 13 of the EU GMP guidelines. This annex details guidance for Investigational Medicinal Products (IMPs), and this handbook will focus only on those Articles applicable to labeling requirements (Articles 26 to 33). For US pharmaceutical companies planning clinical trials in Europe, it is critical to comply with these labeling requirements so as not to experience any delays.

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