Signal management pilot for limited group of companies

On 22 February 2018 a pilot will start for companies with medicinal products under additional monitoring. As from that date signal detection will be obligatory for this limited group of marketing authorisation holders. The pilot is going to last a year, until 22 February 2019. The European Medicines Agency (EMA) will use the results and experiences from this pilot for the next signal management implementation step.

Participants in the pilot

As from 22 February 2018 marketing authorisation holders for medicinal products that are included on the additional monitoring list must 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: The EMA will then inform the company about the follow-up steps. If a signal requires additional assessment, the company must send the follow-up documents to, stating the EPITT number (and, if available, the case number).

Marketing authorisation holders who do not have products under additional monitoring

Marketing authorisation holders who do not have any products on the list of medicines under additional monitoring will, for the time being, not be obliged to carry out signal detection via EudraVigilance. The MEB advises them to wait for the results of the pilot in 2019. They too can report signals from other sources via the 'normal' procedures (PSUR/variation).


The EMA, the national authorities and the companies are jointly responsible for detecting and managing safety signals. Supplementary to the current process, the companies have been given broader access to EudraVigilance as of 22 November 2017. Companies can use the coming months to familiarise themselves with the new system.