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), 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.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.