Article 12

1. Where this measure is activated, the Commission may, when it considers that there is a risk of a shortage of crisis-relevant raw materials, consumables, medical and other devices, equipment and infrastructure, implement, as quickly as possible, in agreement with the Member States concerned and after consultation with the economic operators concerned, specific measures to ensure the efficient reorganisation of supply chains and production lines and utilise existing stocks to increase the availability and supply of crisis-relevant medical countermeasures. 2. In particular, the measures referred to in paragraph 1 may include: facilitating the expansion or repurposing of existing, or the establishment of new, production capacities for crisis-relevant medical countermeasures; facilitating the expansion of existing, or the establishment of new, capacities related to activities and the introduction of measures ensuring regulatory flexibility, in order to support the production and placing on the market of crisis-relevant medical countermeasures, while respecting the responsibilities of EMA and national medicines authorities with regard to the evaluation and supervision of medicinal products; implementing procurement initiatives, reserving stockpiles and production capacities to coordinate approaches, and providing critical supply, services and resources for the production of crisis-relevant medical countermeasures; facilitating the collaboration of relevant companies in a joint industry effort to ensure the availability and supply of crisis-relevant medical countermeasures; and facilitating the licensing of intellectual property and know-how pertaining to the crisis-relevant medical countermeasures. 3. The Commission may provide timely financial incentive mechanisms necessary to ensure the rapid implementation of the measures referred to in paragraph 2.

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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.