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The QRD guidance specifies that from 11 May 2024, new abbreviations and pictograms can replace existing labeling information on veterinary medicinal products.
This guidance ensures proper identification and comprehension of veterinary medicines by users and facilitates compliance with EU regulations, ultimately enhancing safety and efficacy in the veterinary medicine sector.
Marketing authorization holders (MAHs) must review and potentially update their product labeling to align with the new regulations by 11 April 2029 for products authorized before 11 May 2024.
Regulatory Intelligence Lead
Quarterly monitoring recommended until compliance deadline.
Marketing authorization holders (MAHs) must review and potentially update their product labeling to align with the new regulations by 11 April 2029 for products authorized before 11 May 2024.
The European Medicines Agency (EMA) has introduced guidance pertaining to the implementation of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorized through various EU procedures including centralised, mutual recognition, decentralized, and national procedures. This guidance outlines the transitional period and specifics for compliance, including dates and applicability for new marketing authorisations.
What changed: The QRD guidance specifies that from 11 May 2024, new abbreviations and pictograms can replace existing labeling information on veterinary medicinal products.
Why it matters: This guidance ensures proper identification and comprehension of veterinary medicines by users and facilitates compliance with EU regulations, ultimately enhancing safety and efficacy in the veterinary medicine sector.
Practical implication: Marketing authorization holders (MAHs) must review and potentially update their product labeling to align with the new regulations by 11 April 2029 for products authorized before 11 May 2024.
Published from the regulator source ingestion pipeline after PV impact triage.
Regulatory teams should integrate the new labeling information into their literature surveillance processes to ensure compliance and accurate communication surrounding Spikevax usage.
Healthcare organizations should review the NPRA annual report to ensure compliance with updated safety monitoring practices and adjust their reporting and signal management processes accordingly.
Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.
Regulatory Intelligence Leads must incorporate the new reporting requirements and deadlines into their monitoring activities for affected products.
