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The goal is to create an environment where external whistleblowers feel confident to:
EMA's whistleblowing policy (policy 0072) available below provides a framework for assessing reports from external whistleblowers and coordinating any further investigation. It also protects the confidentiality of the reporting person.
EMA published its latest revision of this policy in October 2026. This revision further aligns the policy with Directive (EU) 2019/1937 on protecting persons who report breaches of EU law.
EMA first published this policy in 2017.
EMA has a separate whistleblowing policy for its staff, including seconded national experts, trainees and interims.
For more information, see:
Anyone external to EMA who becomes aware of breaches that might have an impact on EMA's activities may report these allegations to EMA, by writing to reporting@ema.europa.eu.
They should preferably use the template below:
They can also send a letter to EMA.
For information on the EMA's postal address, see:
EMA sends an acknowledgement of receipt, by letter or email, within 7 days after receiving the report. Additional information might be requested from the reporting person, if needed.
The Agency always informs the reporting person of the outcome of the assessment, unless they have chosen to remain anonymous.
EMA notifies whistleblowers if it transfers the report to another competent authority for investigation. This happens when the reported breach falls outside of EMA's remit.
If the allegations concern a centrally authorised medicine, EMA coordinates an investigation. If there are any concerns that the allegations may affect the balance of benefits and risks of the medicine, EMA's scientific committees may consider taking regulatory action.
If the allegations concern a nationally authorised medicine, EMA may, following a case-by-case basis assessment, refer the matter to the national competent authority in the European Union Member State where the concerned medicine is authorised. It will be up to the national competent authority concerned to further investigate the case and take any necessary action, as appropriate, and to inform the Agency of the outcome.
If there is a suspicion of fraud, the Agency refers the case to the European Anti-Fraud Office (OLAF) or to the European Public Prosecutor's Office (EPPO).
For more information, see:
EMA keeps the identity of the reporting person strictly confidential, whether the information provided leads to further investigation or not.
When transferring a report to another authority, the Agency only includes personal data if the external reporting person agrees to this.
EMA treats all personal data that it collects from external whistleblowers in accordance with the Regulation for data protection for EU institutions (Regulation (EU) 2018/1725), also known as the EU DPR.
For more information, see:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in October 2026.
2 October 2026
'Policy and procedure' section updated to reflect the latest revision of EMA's whistleblowing policy.