Recital 15

(15) This Regulation should not duplicate the existing framework for medicinal products, medical devices or other medical countermeasures under the EU Health Security Framework, including Regulations (EU) 2022/123 (5), (EU) 2022/2370 (6) and (EU) 2022/2371 (7) of the European Parliament and of the Council and Council Regulation (EU) 2022/2372 (8) regarding crisis preparedness and response in the area of health. The EU Health Security Framework should take precedence over this Regulation as regards supply chain disruptions and shortages of medicinal products, medical devices or other medical countermeasures where the conditions of that framework are met. Therefore, medicinal products, medical devices or other medical countermeasures within the meaning of Regulations (EU) 2022/2371 and (EU) 2022/2372 should, where they have been included in the list adopted pursuant to Article 7(1) of Regulation (EU) 2022/2372, be excluded from the scope of this Regulation, except in relation to the provisions relating to the free movement of goods, services and persons, including workers, during an internal market emergency, and in particular those designed to re-establish and facilitate free movement.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-27 · Text as adopted (Official Journal); later amendments are not incorporated in this text.