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3.

Where the approval provides for the submission of further confirmatory information as referred to in Article 6(f), the Regulation shall provide the time limit to submit the information to the Member States, the Commission and the Authority. The rapporteur Member State shall assess the additional information and submit its assessment to the other Member States, the Commission and the Authority without delay and at the latest six months after the receipt of the additional information.

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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.