art_20__para_1__para
The risk assessment shall be carried out in the case of a threat referred to in Article 2(1) of this Regulation in cooperation with the European Union Agency for Law Enforcement Cooperation (Europol) where the serious cross-border threat to health emanates from terrorist or criminal activity referred to in Article 3 of Regulation (EU) 2016/794 of the European Parliament and of the Council (42); and in cooperation with EMA, where the serious cross-border threat to health is linked to medicinal products.
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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.