PharmacovigilanceOfficial

EMA publishes PSUSA outcome for perchlorates, with marketing authorisations maintained

🇪🇺 EMA · Fri 30 Oct 2026

The European Medicines Agency has released the single assessment outcome for perchlorates, recording a 'maintenance' result for the active substance under procedure PSUSA/00002486/202603.

The European Medicines Agency (EMA) published the outcome of a periodic safety update report single assessment (PSUSA) for perchlorates on 30 October 2026. The procedure is numbered PSUSA/00002486/202603 and covers human medicines.

The regulatory outcome is listed as 'maintenance'. The source gives no further detail on the assessment, such as safety findings, changes to product information or follow-up measures.

EMA has also posted a document headed 'Perchlorates: List of nationally authorised medicinal products' for the procedure. It is an English-language PDF of 159.49 KB, with the reference number EMADOC-1700519818-3537529.

As general context, a PSUSA is a single assessment of related periodic safety update reports (PSURs) for an active substance contained in medicines authorised in the EU. A PSUR is a pharmacovigilance report that marketing-authorisation holders submit regularly at defined points after authorisation.

What it means for your team

  • Marketing-authorisation holders with nationally authorised perchlorate-containing products should check the published product list to confirm whether their medicines are included.
  • The 'maintenance' outcome is the only regulatory result stated in the source; no variation or other action is mentioned there.
  • Pharmacovigilance teams should consult the full EMA procedure page and document for any detail beyond this summary before updating internal records.

Official source: EMA ↗

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

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