Recital 35

(35) The recognition of public health emergencies and the legal effects of this recognition provided for in Decision No 1082/2013/EU should be broadened. To that end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of such emergency recognition. The advisory committee should consist of independent experts, including representatives of healthcare and social care workers and civil society representatives, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring. Representatives of the Member States, of the ECDC, of EMA, and of other Union agencies or bodies or of the WHO, should be able to participate as observers. All members of the Advisory Committee should provide declarations of interest. Recognition of a public health emergency at Union level should provide the basis for introducing operational public health measures for medicinal products and medical devices, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as the ‘EU Health Task Force’.

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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.