3.

For the purposes of paragraph 2, during public health emergenciesand major events: marketing authorisation holders shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(2), point (a), in accordance with Articles 9 and 10; Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(1), point (d), in accordance with Articles 9 and 11. The reporting referred to in the first subparagraph, point (b), shall include information in addition to that referred to in that point received from marketing authorisation holders and wholesale distributors, or other persons or legal entities that are authorised or entitled to supply to the public medicinal products included on the critical medicines lists, where relevant.

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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.