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1. The Agency, in collaboration with Member States, shall continuously monitor any event that is likely to lead to a public health emergency or major event. As necessary, the Agency shall cooperate with the European Centre for Disease Prevention and Control (‘ECDC’) and, where relevant, other Union agencies.

2. To facilitate the monitoring referred to in paragraph 1, the national competent authorities for medicinal products, acting through the single points of contact referred to in Article 3(6), second subparagraph, or the platform referred to in Article 13 (the ‘ESMP’), once it is fully functional, shall report in a timely manner to the Agency ◄ on any event that is likely to lead to a public health emergency or major event, including an actual or potential shortage of a medicinal product in a given Member State. Such reporting shall be based on the reporting methods and criteria pursuant to Article 9(1), point (b).

Where a national competent authority informs the Agency of a shortage of a medicinal product as referred to in the first subparagraph, it shall provide the Agency with any information that it has received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC, if that information is not available in the ESMP. Where the Agency receives a report of an event from a national competent authority for medicinal products, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(6), in order to evaluate the impact of the event in other Member States.

3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall raise the issue of concern with the MSSG. Following a positive opinion of the MSSG, the Commission may recognise the major event. The Commission or at least one Member State may raise the issue of concern with the MSSG on its own initiative.

4. The MSSG shall inform the Commission and the Executive Director of the Agency once the MSSG considers that the major event has been sufficiently addressed and considers that its assistance is no longer needed. On the basis of the information referred to in the first subparagraph or on its own initiative, the Commission or the Executive Director may confirm that the major event has been sufficiently addressed and therefore that the assistance of the MSSG is no longer needed.

5. Following the recognition of a public health emergency or the recognition of a major event in accordance with paragraph 3 of this Article, Articles 5 to 12 apply as follows:

(a) where the public health emergency or the major event may affect the quality, safety or efficacy of medicinal products, Article 5 applies;

(b) where the public health emergency or the major event may lead to shortages of medicinal products in more than one Member State, Articles 6 to 12 apply.