(b)
If the Agency concludes that the safety problem cannot be addressed in accordance with point (a), it shall, within the period referred to in that point, issue a recommendation in accordance with Article 18(b) as to whether this Regulation or its implementing rules should be amended and whether the notified measures should be withdrawn or maintained.
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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.