art_11__para

The authorization provided for in Article 4 shall be withheld if examination of the documents and particulars listed in Article 5 establishes that: 1. the veterinary medical product is harmful under the conditions of use stated at the time of application for authorization, has no therapeutic effect or the applicant has not provided sufficient proof of such effect as regards the species of animal which is to be treated, or its qualitative or quantitative composition is not as stated;

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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.