Reporting an adverse event or product complaint
This page explains how to report a suspected side effect, a quality defect or any other problem with a product we distribute.
Use this channel for
Adverse events
Any unwanted or unexpected effect experienced after using a product, whether or not you believe the product caused it.Quality defects
Damaged, discoloured, contaminated or otherwise abnormal product, packaging or labelling.Product complaints
Anything about a product that did not meet the standard you expected of it.Suspected falsified product
Product you believe may not have come through a legitimate supply route.
Safety reporting
24/7 hotline
Pending confirmation
Send the report by email
Write to our safety reporting address. Reports are received by our medical team, recorded, and forwarded to the company that holds the marketing authorisation for the product.
Information that helps us act
Send what you have. A report is worth making even if you cannot answer everything below.
- The product name and, if you have it, the batch number and expiry date
- A description of what happened and when it started
- The age and sex of the person affected, without naming them if you prefer
- Any other medicines being taken at the time
- How we can reach you if we need to ask a follow-up question
Before you use this channel
This is not an emergency service
This channel is not monitored for medical emergencies and we cannot give medical advice. If someone needs urgent care, contact a healthcare professional or emergency services.
This does not replace national reporting
Reporting to us does not replace reporting to the national health authority. You are free to do both, and we encourage it.
How reports are handled
Reports are treated as confidential health information. Personal details are shared only with the marketing authorisation holder and, where required, the health authority, and only to the extent needed to assess the report.
Reports reaching any of our channels are recorded and forwarded to the marketing authorisation holder within the applicable timelines. A dedicated address is published so that reports are not lost in general correspondence.