PharmacovigilanceOfficial

EMA publishes list of Union reference dates and PSUR submission frequencies

🇪🇺 EMA · Wed 21 Oct 2026

The EU regulator has issued its list setting reference dates and frequencies for periodic safety update report submissions; the entry-level details were not available to VigiEye.

The European Medicines Agency (EMA) published an item dated 21 October 2026 titled "List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)".

The material available to VigiEye contained only the title, with no accompanying text. We therefore cannot say which active substances or combinations are affected, whether dates or frequencies have changed, or when any change takes effect.

By way of context, the EU reference date list (EURD list) sets harmonised PSUR submission dates and frequencies for medicines containing the same active substance or combination. Marketing authorisation holders use it to plan their periodic safety reporting.

Teams should consult the full list on the EMA website for the specific entries relevant to their products.

What it means for your team

  • Pharmacovigilance teams should check the latest EURD list against their PSUR submission calendars for any affected active substances.
  • Regulatory affairs staff should confirm that any change to a reference date or frequency is reflected in internal tracking and in planning for affected products.
  • Details of this particular publication were not available, so no conclusions should be drawn until the full list has been reviewed.

Official source: EMA ↗

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

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