Article 1

1. This Regulation establishes a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency (‘the emergency framework’). 2. The emergency framework shall include: the establishment of a Health Crisis Board; the monitoring, procurement and purchase of crisis-relevant medical countermeasures and crisis-relevant raw materials; the activation of emergency research and innovation plans, including the use of Union-wide clinical trial networks and data-sharing platforms; emergency Union funding, including under Regulation (EU) 2016/369; measures concerning the production, availability and supply of crisis-relevant medical countermeasures, including the establishment of an inventory of crisis-relevant medical countermeasures production and production facilities, and, as appropriate, of crisis-relevant raw materials, consumables, medical devices, equipment and infrastructure, and including measures aimed at increasing their production in the Union. 3. The emergency framework may be activated only to the extent that it is appropriate to the economic situation, taking into account the need to ensure a high level of protection of human health.

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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.