The world of pharmaceuticals is constantly evolving, with regulations and guidelines being updated to ensure the safety and efficacy of medicinal products. One such recent update comes from the European Medicines Agency (EMA), which has revised the Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'.

This update, effective from 17/04/2024, specifically targets marketing authorisation holders (MAH's) with products containing polysorbates. These MAH's are now required to update their Product Information via relevant variations in order to comply with the new guidelines.

The guideline itself contains a comprehensive list of excipients with known actions or effects, which must be clearly stated on the labelling of medicines in the European Union (EU). Additionally, the guideline outlines the information that should appear in the package leaflet accompanying the product. It is crucial for marketing authorisation holders to take the necessary steps to implement any revised wording in the package leaflet at the earliest opportunity.

For medicines that do not have any upcoming regulatory submissions, marketing authorisation holders are advised to submit a type IB variation within 3 years of the revision date of the relevant excipient. This proactive approach ensures that all products are in compliance with the updated guidelines.

If you are a marketing authorisation holder who requires assistance with this update, do not hesitate to reach out. Our team is here to support you through this process and ensure that your products meet the necessary regulatory standards.

By staying informed and taking proactive steps to comply with these guidelines, MAH's can continue to provide safe and effective products to patients across the EU.

Stay ahead, stay compliant, and keep saving lives in the pharmaceutical industry! 💊📦 #EMAUpdate #PharmaLife #RegulatoryCompliance