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 [e-mail]:

• (Suspected) falsified medicinal product report

  Note: This form needs to be opened with a PDF reader. EMA advises to save the document first, and then open with a PDF reader, such as Acrobat Reader.

For guidance on using the template, see:

• How to use the (suspected) falsified medicinal product report template to report a case of (suspected) falsified medicinal product 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 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.