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.

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