The EMA, the national authorities and the companies are jointly responsible for detecting and managing safety signals. A pilot was running from February 2018 to July 2025 for companies that offer medicinal products that are on the pilot list.
Update august 2025
The pilot on signal detection by Marketing Authorisation Holders (MAHs) in EudraVigilance is terminated as of entry into force of the Implementing Regulation (EU) 2025/1466 (IR 2025/1466) on 22 July 2025.
The requirements established in the updated Implementing Regulation will be applicable to all MAHs with medicinal products authorised in the EEA. The standalone signal notification form for signals detected in EudraVigilance no longer applies. Signals detected through all sources, including signals identified in the EudraVigilance database, should be handled according to the MAH’s own signal management process. MAHs are expected to implement the changes following IR 2025/1466 from the twentieth day following the publication in the Official Journal of the European Union.
EMA has published a Questions and Answers document to provide practical guidance and support to MAHs in adapting to the updated obligations. An update of GVP IX will follow (Q1 2026).
Participants in the pilot (superseded)
The information below concerns the pilot, which is terminated in July 2025.
As from 22 February 2018, marketing authorisation holders for medicinal products that are included on the pilot list have been required to inform the authorities about safety signals from EudraVigilance. The companies can continue to report signals from other sources via the 'normal' procedures (PSUR/variation). Instructions for reporting signals from EudraVigilance have been published on the EMA website.
This means, specifically for the Dutch situation, that the company must send the initial submission of the signal to the EMA, with a copy being sent to the Dutch email address: MAHnewsignals@cbg-meb.nl. The EMA then informs the company about the follow-up steps. If a signal requires additional assessment, the company must send the follow-up documents to case@cbg-meb.nl, with a reference to the EPITT number (and, if known, the case number).
Marketing authorisation holders that do not have products for additional monitoring
Marketing authorisation holders that do not have any products on the pilot list are, for the time being, not obliged to carry out signal detection via EudraVigilance. They too can report signals from other sources via the 'normal' procedures (PSUR/variation). These companies are also allowed to use the data from EudraVigilance when drawing up a PSUR.