Article 18

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products · European Union

1. If, within a period of 120 days after the date of forwarding of the information referred to in Article 17 (2), no objection has been notified to the Committee by the competent authorities of the Member States specified, the Committee shall formally record the fact and forthwith inform the Member States concerned. 2. Where a Member State considers that it is unable to grant marketing authorization, it shall forward its reasoned objection based on Article 11 within the said period of 120 days.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.