Reporting a quality defect to EMA

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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.

Reporting instructions

Step 1. Notify EMA 

Complete the defective product report template and submit to qdefect@ema.europa.eu (or fax to +44 (0)20 3660 5535):

 

 

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:

 

  • Tel. +44 (0)20 3660 6000 (EMA switchboard)
  • Tel. +44 (0)20 3660 7676

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

 

  • Tel. +44 (0)7880 550697
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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.

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Step 3. Keep EMA informed

Keep EMA informed of any changes or additional information immediately.

 

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Contact point:

qdefect@ema.europa.eu