This content applies to human and veterinary medicines.
Step 1. Download the Defective Product Report Form.
Step 2. Complete the Defective Product Report Form ensuring that all of section 1 and as much as possible of sections 2 and 3 are complete. Please do not complete the shaded areas.
Step 3. Send the form by email to email@example.com. If this is not possible you can fax the form to +44 (0)20 3660 5535.
Step 4. During normal working hours you should receive an acknowledgement within 4 hours.If you do not obtain an acknowledgement in this time, telephone the European Medicines Agency to confirm that the Defective Product Report Form has been received.The telephone numbers to use are:
During Office Hours
+44 20 3660 7676
+44 20 3660 6000 (Switchboard)
In urgent cases outside of working hours, at weekends or on Agency public holidays call the number below.In other cases you should expect acknowledgement within 4 hours of the start of the next working day.
Outside office hours
+44 7880 550697
Step 5. Continue to investigate the suspected quality defect (with the urgency indicated by the nature of the defect) and send a report to the European Medicines Agency, which includes at least the following information:
- a. Background information (e.g. information about the product, its manufacturing process and/or use);
- b. History of the incident with specific dates when it occurred and/or was observed);
- c. Potential root cause:
- i. If the problem is due to the presence of a foreign object, describe the foreign object’s size and composition;
- ii. If the problem is due to the presence of a contaminant (i.e. cleaning fluid, machine oil, paint vapours), the level of contamination should be given and the Material Safety Data Sheet for the contaminant should be provided;
- iii. If the problem is due to failure of the product to meet product specifications, provide the specifications and report all test results;
- iv. If the problem is due to a label or formulation issue, provide and identify the correct and incorrect label(s), description(s) and formulation(s);
- d. Describe the corrective and preventive actions taken or to be taken to eliminate the root cause;
- e. Review of complaint records for reports of similar defects;
- f. Review of all associated batch manufacturing, packaging, testing, release and distribution records for anomalies which may explain the suspected defect;
- g. Examination, and retesting, if appropriate, of retained samples;
- h. Estimation of stock under the manufacturer’s control;
- i. Distribution and parallel distribution of the batches affected;
- j. Recommendation on whether a recall is necessary, and if so, to what level;
- k. If recall is recommended, assessment of the classification of the defect;
- l. If recall is recommended, explain whether the problem affects ALL units subject to recall or just a portion of the units. Explain why the problem is restricted only to those products/lots identified;
- m. Overall conclusions
Step 6. Provide a report outlying the risks associated with the suspected quality defect in particular the impact on the safety and/or efficacy of the medicinal product concerned. Outline any risk mitigation measures.
If any delay is expected in making the report of steps 5 and 6, interim reports should be sent not more than 48 hours after the original notification in step 3.
Step 7. Keep the European Medicines Agency informed immediately of any changes or additional information.
Documents of interest:
- Defective Product Report Form
- Classification of Batch Recalls for Product Defects
- Rapid Alert Procedure
For queries please send a question to the European Medicines Agency.
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