Access this content
Your content has been opened.
Sherpa Guide EU Annex 13 Labeling has been emailed to . Entered the wrong email?
Don't see the content in your inbox?
Make sure to check your spam and other messages folders.
Can't get to your email right now?
Please enter a valid verification code.
Code sent to:
Register to access this content
By accessing content on the Pharmaceutical Manufacturing Resource Directory you agree to our Terms of Service and Privacy Policy; and, you acknowledge that your information may be shared with the content publisher.
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.