Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 EU Good Manufacturing Practice - ANNEX 13 | Contract Pharma

What are you searching for?

Sign in
White Papers / Tech Papers

EU Good Manufacturing Practice – ANNEX 13

Investigational Medicinal Products

Released By PCI Pharma Services

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.

DOWNLOAD TO LEARN MORE>>>>

Download White Papers / Tech Papers Now

Download White Papers / Tech Papers Now

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters