3.
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
may, where appropriate, require the applicant to provide further information as regards the items listed in Article 5. Where the competent authorities take this course of action, the time limits specified in Article 8 shall be suspended until the further data required have been provided. Similarly, these time limits shall be suspended for any period which the applicant may be given to provide oral or written explanations.
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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.