Article 11

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; 2. the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated; 3. the veterinary medicinal product is offered for sale for a use prohibited under other Community provisions. However, pending Community rules, the competent authorities may refuse to grant authorization for a veterinary medicinal product where such action is necessary for the protection of public health, consumer or animal health. Authorization shall also be withheld if the application documents submitted to the competent authorities do not comply with Articles 5, 6 and 7.

Council Directive 81/852/EEC of 28 September 1981 on the… (EU) — sign in to see which provisions, and what they say.

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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.