YJB response to the PAVA rollout extension
Monitor compliance practices regarding PAVA use in youth custody settings and assess alignment with the YJB's concerns and evidential claims on efficacy and safety.
Primary source: annotated version of this template
MAHs can now link QR codes on packaging to public-facing educational and instructional material, which was previously restricted to non-public-facing content.
This update enhances the provision of clear, helpful information regarding veterinary medicines, promoting safer and more effective use among pet owners and veterinarians.
Marketing Authorization Holders must update packaging and compliance processes to incorporate QR codes linked to educational materials as per the new guidelines.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Marketing Authorization Holders must update packaging and compliance processes to incorporate QR codes linked to educational materials as per the new guidelines.
The VMD's updated guidance permits marketing authorisation holders (MAHs) to link QR codes on packaging to additional educational and instructional content. This change aims to improve access to product information for veterinarians and pet owners.
What changed: MAHs can now link QR codes on packaging to public-facing educational and instructional material, which was previously restricted to non-public-facing content.
Why it matters: This update enhances the provision of clear, helpful information regarding veterinary medicines, promoting safer and more effective use among pet owners and veterinarians.
Practical implication: Marketing Authorization Holders must update packaging and compliance processes to incorporate QR codes linked to educational materials as per the new guidelines.
Published from the regulator source ingestion pipeline after PV impact triage.
Monitor compliance practices regarding PAVA use in youth custody settings and assess alignment with the YJB's concerns and evidential claims on efficacy and safety.
Update product labels to include prevention indications for Capstar and Nitenpyram Tablets. Ensure that labeling reflects new usage guidelines for these products as outlined in the Emergency Use Authorization.
Review compliance with PREA obligations, prepare responses to any received non-compliance letters, and ensure any necessary deferral extension requests are properly submitted within the specified timeframe.
Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.