PharmacovigilanceOfficial

PRAC publishes new product information wording from September–October 2026 signal recommendations

🇪🇺 EMA · PRAC · Mon 26 Oct 2026

EMA's pharmacovigilance committee has released extracts of product information wording linked to signals it adopted at its 28 September–1 October 2026 meeting.

The European Medicines Agency has published a document headed "New product information wording – extracts from PRAC recommendations on signals". It covers recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 28 September to 1 October 2026. The item is dated 26 October 2026.

The full text of the publication was not available when this article was written. The medicines concerned, the safety issues assessed and the exact wording proposed therefore cannot be reported here. The title indicates that the extracts cover changes to product information that follow from the committee's signal recommendations.

By way of context, a PRAC signal assessment reviews information suggesting a new or changed association between a medicine and an adverse event. Where the committee considers an update warranted, it can recommend changes to the summary of product characteristics and package leaflet. Marketing authorisation holders are then expected to follow up through the relevant variation procedures.

What it means for your team

  • Pharmacovigilance and regulatory teams should read the full EMA document to see whether any of their products are named and what wording is proposed.
  • Where a product is affected, plan the product information variation and any related labelling and leaflet updates against the applicable timelines.
  • Safety and medical information teams may need to align their internal signal-tracking and customer-facing materials with the new wording once it is confirmed.

Official source: EMA · PRAC ↗

Article written by VigiEye from the official source (EMA · PRAC). AI-assisted; check the source before acting.

More Pharmacovigilance All →