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Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level

article  10

CELEX:  32022R2372

Inventory of crisis-relevant medical countermeasure production and production facilities
1. Where this measure is activated, the Commission may, by means of implementing acts, draw up and regularly update an inventory of crisis-relevant medical countermeasure production and production facilities and a template for monitoring of production capacity and stocks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2) and, on duly justified imperative grounds of urgency, in accordance with the procedure for immediately applicable implementing acts referred to in Article 14(3).
Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level

article  10

CELEX:  32022R2372

2. The Commission may, using the template referred to in paragraph 1, request the producers of crisis-relevant medical countermeasures to inform the Commission, within five days, of the actual total production capacity, and possible existing stocks of the crisis-relevant medical countermeasures and components thereof, in their Union production facilities and the third-country facilities which they operate, with which they have contracts, or from which they purchase supplies, while fully respecting trade and business secrets. The Commission may also request those producers to transmit to it a schedule of the expected production output for the following three months for each Union production facility.
3. Upon request of the Commission, each producer of crisis-relevant medical countermeasures shall inform the Commission, within a maximum of five days, of any Union crisis-relevant medical countermeasure production facility it operates, including information on its production capacity as regards such countermeasures by means of regular updates. For medicinal products, that information shall comprise facilities related to both finished products and active pharmaceutical ingredients.
Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level

article  10

CELEX:  32022R2372

4. The Commission shall regularly inform the European Parliament and the Council about the production of crisis-relevant medical countermeasures and the expected production rate within the Union and the production of supplies from third-country facilities, whether the products are finished, intermediates or other components, as well as about the capacity of Union and third-county crisis-relevant medical countermeasure production facilities, while adequately protecting commercially sensitive information of the producers.