Handling reports of alleged improprieties from external sources

The European Medicines Agency (EMA) has put in place a policy on handling allegations of improprieties received from external sources. Such improprieties may include allegations of non-compliance with standards of good practices that could have an impact on the evaluation and supervision of medicines.

The goal is to create an environment where individuals outside the Agency feel confident to raise their concerns on improprieties in their area of work, and submit information or evidence about improprieties they may have observed.

The policy helps EMA assess these reports and coordinate any further investigation, while protecting the confidentiality of the reporting person.

EMA's Management Board adopted the policy in March 2017. It came into effect on 17 March 2017:

How to report a concern

Anyone external to EMA who becomes aware of an irregularity that might impact on EMA's activities may report these allegations to EMA, by writing to reporting@ema.europa.eu, using the provided template.

They can also send a letter to the Agency. For information on the Agency's postal address, see Contacts at EMA.

What EMA will do

EMA sends an acknowledgement of receipt, by letter or email, within 15 working days after receiving the report.

EMA keeps the identity of the reporting person confidential, whether the information provided leads to further investigation or not.

If the allegations concern a centrally authorised medicine, EMAl coordinates an investigation. If there are any concerns that the improprieties may affect the balance of benefits and risks of the medicine, EMA's scientific committees may consider regulatory action.

If the allegations concern a nationally authorised medicine, EMA may, on a case-by-case basis, refer the matter to the national competent authority in the European Union Member State where the concerned medicine is authorised.

If there is a suspicion that fraud is involved, the Agency refers the case to the European Anti-Fraud Office (OLAF) in accordance the existing arrangements between OLAF and EMA. For more information, see Anti-fraud strategy.

EMA inform the reporting person, if not anonymous, of the outcome of the assessment or if it transfers the report to another competent authority.

The Agency only includes personal data when it transfers a report to another party if the reporter agrees to this.

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