FantasticSearch

1. Where this measure is activated, the Commission shall, after seeking the advice of the Health Crisis Board, draw up and regularly update, by means of implementing acts, a list of crisis-relevant medical countermeasures and raw materials, as well as a template for monitoring their supply and demand, including production capacity, stockpiles, possible critical aspects or the risk of disruption in the supply chains and purchasing agreements. 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).

2. The list referred to in paragraph 1 shall include a shortlist of specific crisis-relevant medical countermeasures and raw materials for the preparation of measures to be taken in accordance with this Article and Articles 8 to 13, taking into account the information obtained pursuant to:

(a) Regulation (EU) 2022/123, and in particular Articles 3 to 14 and 21 to 30 thereof, concerning the monitoring and mitigation of shortages of medicinal products and medical devices included in the critical medicines lists and public health emergency critical medical devices list, respectively;

(b) Regulation (EC) No 851/2004, and in particular Article 3(2), point (f), thereof, concerning available data on Member States’ health system capacity necessary to the management and response to communicable disease threats.

3. Without prejudice to national security interests, Member States shall, where appropriate, provide the Commission with additional information not already collected by Union agencies on the basis of the template referred to in paragraph 1.

4. Without prejudice to national security interests and the protection of commercially confidential information resulting from agreements entered into by Member States, where a Member State intends to adopt at national level measures for the procurement, purchase or manufacturing of crisis-relevant medical countermeasures or raw materials from the list referred in paragraph 1, it may inform the Health Crisis Board in a timely manner.

5. Upon request of the Commission, including on behalf of the Health Crisis Board, EMA shall provide it with information with regard to monitoring of medicinal products and medical devices, including their demand and supply, in accordance with Article 9(2), points (c) and (d), and Article 25(2), points (c) and (d), of Regulation (EU) 2022/123.

6. The Commission shall gather additional information not already collected by Union agencies through a secured IT system and monitor, on the basis of the template referred to in paragraph 1, all relevant information concerning the supply and demand of crisis-relevant medical countermeasures and raw materials within and outside the Union. The Commission shall ensure the interoperability of the IT system with the electronic monitoring and reporting systems developed by EMA pursuant to Article 9(1), point (c), of Regulation (EU) 2022/123.

7. The Commission shall regularly provide information on the results of the monitoring of crisis-relevant medical countermeasures and raw materials to the European Parliament and to the Council. The Commission shall make available to the European Parliament, to the Council and to the Health Security Committee modelling and forecasts regarding the needs for crisis-relevant medical countermeasures and raw materials with, where appropriate, the support of relevant Union agencies. The Commission shall subsequently inform the Health Crisis Board of the monitoring and its results.