Article 28

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. The Member States shall take all appropriate measures to ensure that the time taken for the procedure for granting the authorization referred to in Article 24 does not exceed 90 days from the day on which the competent authority receives the application. 2. If the holder of the authorization requests a change in any of the particulars referred to in Article 25 (a) and (b), the time taken for the procedure relating to this request shall not exceed 30 days. In exceptional cases, this period of time may be extended to 90 days. 3. Member States may require from the applicant further information concerning both the particulars supplied pursuant to Article 25 and the qualified person referred to in Article 29 ; where the competent authority concerned exercises this right, application of the time limits referred to in paragraphs 1 and 2 shall be suspended until the additional data required have been supplied.

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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.