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2.3. Restrictions on approval

Where necessary, the approval may be subject to conditions and restrictions as referred to in Article 6. Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed.

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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.