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4.

Within 90 days of receipt of the additional information referred to in paragraph 3, the Commission shall prepare a draft of the measures to be taken, which shall forthwith be communicated to the Member States and the person responsible for marketing. Within a further 60 days, the person responsible for marketing may, at his request, provide oral or written explanations for consideration by the Committee for Veterinary Medicinal Products. The Commission may, at the request of the applicant, extend this time limit.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.