Primary source: EMA - What's new RSS
Translated From French
PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.
Updated details for HR and CZ national adverse event reporting systems have been included in Version 6 of this document.
Accurate reporting of adverse events is crucial for veterinary pharmacovigilance; these updates are essential for ensuring compliance with the latest regulatory requirements in the respective member states.
Ensure that only the current national adverse event reporting details for HR and CZ are displayed on veterinary product packaging, as per the updated guidelines.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Ensure that only the current national adverse event reporting details for HR and CZ are displayed on veterinary product packaging, as per the updated guidelines.
The European Medicines Agency (EMA) has released Version 6 of the QRD veterinary Appendix I, which includes specific updates for national adverse event reporting systems in HR and CZ as of September 2026, affecting the way adverse events should be documented in veterinary product packaging.
What changed: Updated details for HR and CZ national adverse event reporting systems have been included in Version 6 of this document.
Why it matters: Accurate reporting of adverse events is crucial for veterinary pharmacovigilance; these updates are essential for ensuring compliance with the latest regulatory requirements in the respective member states.
Practical implication: Ensure that only the current national adverse event reporting details for HR and CZ are displayed on veterinary product packaging, as per the updated guidelines.
Published from the regulator source ingestion pipeline after PV impact triage.
Review the updated guidance to incorporate the new compliance procedures starting from 1 January 2026, specifically regarding the electronic submission process.
Marketing authorization holders must implement processes to ensure timely submissions of required data within the defined 15 and 30 calendar day timelines, including details of the Qualified Person responsible for Pharmacovigilance and the submission of Pharmacovigilance System Master File information.
Update labeling materials for Gardasil 9 to incorporate new safety and efficacy data as per the revised EPAR.
The pharmacovigilance department must increase reporting obligations for any adverse effects related to Rezolsta as part of ongoing safety monitoring.
