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1.

The provisions of this Regulation and of rules adopted for its implementation shall not prevent a Member State from reacting immediately to a safety problem which involves a product, person or organisation subject to the provisions of this Regulation. If the safety problem is the result of: an inadequate level of safety resulting from the application of this Regulation; or a shortcoming in this Regulation or its implementing rules; the Member State shall immediately notify to the Agency, the Commission and the other Member States the measures taken and the reasons therefor.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.