5.

By way of derogation from paragraphs 3 and 4, in the case of urgent preventive measures, where the examination referred to in paragraph 1 leads to a negative assessment and if the Member State concerned has not amended or repealed the national rule in question within 2 months of receipt of the opinion of the Agency, the Commission may adopt a decision, by way of implementing acts, requesting the Member State to amend or repeal that rule. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 81(2). In the case of a positive assessment by the Agency and if the national rule in question has an impact on more than one Member State, the Commission, working in cooperation with the Agency and Member States, shall take the appropriate measures, including the revision of CSMs and TSIs where necessary.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-28 · Text as adopted (Official Journal); later amendments are not incorporated in this text.