Emerging safety issue

A safety issue considered by a marketing authorisation holder to require urgent attention by the competent authority because of the potential major impact on the risk-benefit balance of the medicinal product and/or on patients’ or public health and the potential need for prompt regulatory action and communication to patients and healthcare professionals.

Examples include:

• major safety issues identified in the context of ongoing or newly completed studies, e.g. an unexpectedly increased rate of fatal or life-threatening adverse events;
• major safety issues identified through the spontaneous reporting system or publications in the scientific literature, which may lead to considering a contraindication, a restriction of use of a medicinal product or its withdrawal from the market;
• major safety-related regulatory actions outside the EU, e.g. a restriction of use of a medicinal product or its suspension.