ANNEX 13 Investigational Medicinal Products - Labeling Requirements Explained

What’s the importance of Annex 13 labeling requirements?

Can you imagine working for months to ensure your clinical supply strategy is in place for your European studies, only to have them be delayed because labeling requirements were out of compliance, and the QP or the site(s) rejected the materials you wanted to use in a trial?

The European pharmaceutical market is expected to grow to 206 billion euros in 2022, making it an enticing market to companies worldwide.1 It is also one of the most well regulated regions that requires a thorough understanding of common challenges and pitfalls for initiating clinical studies. The European Union (EU) currently comprises 28 individual countries with approximately 22 official languages spoken. Sponsor companies looking to hold clinical studies in the EU must comply with set EU Directives and EU Good Manufacturing Practice (GMP) guidelines.

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.

While most EU countries will accept the standard Annex 13 requirements for standard trials, there are some countries that have additional requirements. For example, some national authorities may require the inclusion of a trial number or a EudraCT number that is logged with the national authorities in a database.