Variation Implementation Times for Labelling and Leaflet Updates to Human Medicines: Update on Regulatory Flexibility during the COVID-19 Pandemic

News Category: Regulatory news

Date: 18/05/2020

The HPRA has agreed to extend the permitted implementation time from six months to nine months for labelling and/or package leaflet updates following variation approval for the duration of the COVID-19 pandemic. This is a temporary measure only and it will be kept under review. The HPRA has taken this decision to help maintain medicines availability in Ireland during this exceptional time.

It is important to highlight that this extension to nine months does not apply to the implementation of significant safety updates to the labelling and/or package leaflet. Significant safety updates will still need to be implemented within the six-month timeframe. The marketing authorisation holder (MAH) is therefore advised to carry out an evaluation of the specific nature of the updates to the labelling and/or package leaflet before allowing the extended implementation period.

In general, the standard implementation period will still apply to significant safety updates to sections 4.1, 4.2, 4.3 and 4.4 of the SmPC which have implications for the labelling and/or package leaflet. The addition of new safety information to other sections of the labelling and/or package leaflet, such as interactions, driving information, pregnancy/breastfeeding advice, adverse events or overdose information also requires implementation within the six month timeframe in cases where new significant safety information has been added to the labelling and/or package leaflet as a result of the variation.

The implementation of all other variations can be extended to nine months without the need for a batch-specific request, provided that the MAH is satisfied that the update is not concerned with significant safety-related changes.

For queries related to product-specific concerns, please e-mail Customer Services at inserting COVID-19 into the subject line.

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