The EMA, the national authorities and the companies are jointly responsible for detecting and managing safety signals. A pilot has been running since 22 February 2018 for companies that offer medicinal products that are on the pilot list. As from that date, signal detection via the EudraVigilance database has been obligatory for this limited group of marketing authorisation holders.
The pilot is expected to run until the end of 2022. 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 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.