Article 8

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

Member States shall take all appropriate measures to ensure that the procedure for granting marketing authorization is completed within 120 days after the date of submission of the application. In exceptional cases this time limit may be extended for a further 90 days. The applicant shall be notified of such extension before the expiry of the initial time limit.

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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.