10/11 April 2024
Marketing and manufacturing authorization holders should report a quality defect of a centrally authorized medicine, including suspected defects, to EMA following the instructions provided.
The EMA's ("European Medicines Agency") "Defective product report template", which is supposed to be used for notifications of drug product quality defects to the EMA, has recently been updated. Inter alia, the document has been aligned with the terminology of the "Medical Dictionary for Regulatory Activities (MedDRA)". Furthermore, the template is now designed in a more user-friendly manner. Also, detailed instructions on how to use the template (How to use the defective product report to notify a quality defect to European Medicines Agency) have been published and the notes on how to report quality defects to the EMA have been updated. The aforementioned documents can be found on the EMA website under Quality defects and recalls - "Reporting a quality defect to EMA".
The aim is to harmonize the process of reporting and investigating product quality defects of centrally authorized medicinal products. The EMA also encourages national competent authorities to use this template in their national reporting.