COVID-19 Regulatory Flexibility - HPRA Publishes  Updated Implementation Time for Labels and Leaflets

Health Products Regulatory Authority (HPRA) of Ireland has released a temporary measure to extend the permitted implementation time for labeling and/or package leaflet updates from six to nine months. It is a temporary decision, implemented to ensure the availability of medicines in Ireland during pandemic. 

The extension does not apply to implementation of significant safety updates for the labeling and/or package leaflet. The standard implementation period of six months will as usually apply to significant safety updates to sections 4.1, 4.2, 4.3 and 4.4 of the Summary of Product Characteristics (SmPC). In such case, the Market Authorization Holder is advised to evaluate the nature of the update before allowing the extended implementation period.

If new significant safety information is added to other sections of the label such as interactions, pregnancy/breastfeeding advice, adverse events or overdose information, it must be implemented within six-months.

If the update on information is not in relation to significant safety-related changes, the implementation time can be extended to nine months without the need for a batch-specific request. In these challenging times, it is advisable that manufacturers and MAHs evaluate the information with utmost accuracy.  For complete understanding of the HPRA implementation time for labeling and leaflet updates and best practices, consult a Regulatory expert. Stay informed. Stay safe.