PharmacovigilanceOfficial

EMA publishes QRD Appendix V on adverse-drug-reaction reporting details for product information

🇪🇺 EMA · Tue 03 Nov 2026

The agency has issued Appendix V of the QRD documentation, covering the standard statement and contact details for reporting suspected adverse reactions; the changes are not specified.

The European Medicines Agency (EMA) has published QRD Appendix V, titled 'Adverse-drug-reaction reporting details'. The document sets out the standard statement and contact information used in product information so that suspected adverse reactions can be reported.

The material available to VigiEye does not say what has changed in this version. The source text could not be accessed, and the short summary on file does not state whether any wording or national reporting details have been revised.

Because of that, it is not yet clear whether marketing authorisation holders will need to update summaries of product characteristics (SmPCs) or package leaflets. Teams should check the published appendix itself to see whether any text or national contact entries differ from the version they currently use.

As general context, the QRD (Quality Review of Documents) templates and appendices are the reference tools applied to the format and wording of EU product information.

What it means for your team

  • Regulatory affairs teams should compare the new Appendix V with the version currently used in their product information templates.
  • Pharmacovigilance teams should confirm that national reporting contact details in labelling match those in the published appendix.
  • No update to SmPCs or leaflets can be assumed or ruled out until the document's changes are checked, as the summary does not specify them.

Official source: EMA ↗

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

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