Reporting a quality defect to EMA
This content applies to human and veterinary medicines.
Marketing and manufacturing authorisation holders should report a quality defect of a centrally authorised medicine, including suspected defects, to EMA following the instructions provided.
For general information on product quality defects assessment and reporting obligations, see Quality defects and recalls.
Step 1. Notify EMA
Complete the defective product report template and submit to email@example.com:
For guidance on using the template, see:
You should receive an acknowledgement in four hours during EMA business hours. If you do not, you can phone EMA on:
Outside of EMA business hours, use the following urgent contact number:
Step 2. Provide investigation and health hazard assessment reports
If the root case is not identified, continue to investigate the quality defect (according to the urgency indicated by the nature of the defect) and provide a final investigation report and health hazard assessment report as soon as available.
If these final reports are not available when notifying EMA, provide interim reports no later than 48 hours after the original notification until the final reports are available.
The investigation report should contain as a minimum:
The health hazard assessment report should highlight the impact of the reported quality defect on safety and efficacy of the medicine concerned.
Step 3. Keep EMA informed
|Keep EMA informed of any changes or additional information immediately.|