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1. National competent authorities or the Commission shall notify an alert in the EWRS, where the emergence or development of a serious cross-border threat to health fulfils the following criteria:

(a) it is unusual or unexpected for the given place and time, it is causing or may cause significant morbidity or mortality in humans, it is growing rapidly or may grow rapidly in scale, or it is exceeding or may exceed national response capacity;

(b) it affects or may affect more than one Member State; and (c) it requires or may require a coordinated response at Union level.

2. Where the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern, and in the absence of full interoperability between the WHO notification system and the EWRS, national competent authorities shall simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation.

3. When notifying an alert, the national competent authorities and the Commission shall promptly communicate through the EWRS any available relevant information in their possession that may be useful for coordinating the response such as:

(a) the type and origin of the agent;

(b) the date and place of the incident or outbreak;

(c) means of transmission or dissemination;

(d) toxicological data;

(e) detection and confirmation methods;

(f) public health risks;

(g) public health measures implemented or intended to be taken at national level;

(h) measures other than public health measures, including multi-sectoral measures;

(i) whether there is an urgent need for or shortage of medical countermeasures;

(j) requests and offers for cross-border emergency assistance, such as the medical transfer of patients or provision of healthcare staff by one Member State to another, in particular in cross-border areas in neighbouring regions;

(k) personal data necessary for the purpose of contact tracing in accordance with Article 28;

(l) any other information relevant to the serious cross-border threat to health in question.

4. The Commission shall make available to the national competent authorities through the EWRS any information that may be useful for coordinating the response referred to in Article 21, including information relating to serious cross-border threats to health and public health measures related to serious cross-border threats to health, already transmitted through rapid alert and information systems established under other provisions of Union law or the Euratom Treaty.

5. Member States shall update the information referred to in paragraph 3 as new data become available.