Reporting a quality defect to EMA

Marketing and manufacturing authorisation holders should report a quality defect of a centrally authorised medicine, including suspected defects, to EMA following the instructions provided.

This content applies to human and veterinary medicines.

For general information on product quality defects assessment and reporting obligations, see Quality defects and recalls.

Reporting instructions

Step 1. Notify EMA

Complete the defective product report template and submit to [e-mail]:

To open the form below, you need to use a PDF reader. You should save the document first, then open it with a PDF reader such as Acrobat Reader. To report any technical issues with the forms, please use the EMA Service Desk (ServiceNow) portal.

• Defective product report form

For guidance on using the template, see:

• How to use the defective product report to notify a quality defect to European Medicines Agency

You should receive an acknowledgement in one working day during EMA business hours. If you do not, you can phone EMA on:

• Tel. [phone] (EMA switchboard)
• Tel. [phone]

Outside of EMA business hours, use the following urgent contact number:

• Tel. [phone]

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 root cause of the defect.
• the main steps taken in the investigation including an examination of any related batch manufacturing, packaging, testing, release and distribution records;
• examination and retesting of retained samples, if appropriate;
• estimation of stock under the manufacturer's control;
• distribution and parallel distribution of the batch(es) affected (if known);
• information on any market disruption foreseen including list of impacted countries and stock availability;
• if a recall is being proposed, provide information on:
   
  
  • the proposed classification of the defect;
  • the proposed recall action;
  • whether the problem affects all or only a portion of the units subject to the recall, with explanation.
• immediate and long-term corrective action and preventive actions (CAPAs);
• overall conclusions.

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.