Reporting a falsified product to EMA

Marketing and manufacturing authorisation holders should report any falsified centrally authorised medicine to the European Medicines Agency (EMA), including a suspected falsified medicine, following the instructions provided.

For general information on falsified medicines and reporting obligations, see Falsified medicines: reporting obligations .

Reporting instructions

Step 1. Notify EMA

Complete the falsified medicinal product report template and submit to

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. +31(0)88 781 6000 (EMA switchboard)
  • Tel. +31(0)88 781 7676

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

  • Tel. +31(0)65 008 9457

Step 2. Provide authenticity testing report

Provide the authenticity testing report, describing whether the falsification is confirmed or not.

For a confirmed falsification, provide details of the discrepancies in relation to the authentic product (for example, the outer labelling or content).

If these final reports are not available when notifying EMA, provide interim reports, as requested by EMA.

Parallel distributors notifying EMA of a suspected falsified medicine before informing the marketing authorisation holder should also liaise directly with the marketing authorisation holder and provide a sample of the suspicious unit for authenticity testing.


Step 3. Keep EMA informed

Keep EMA immediately informed of any changes or additional information.


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