Article 33

Without prejudice to other provisions of Community law, the authorization provided for in Article 3 shall be refused if, after verification of the information and particulars submitted in accordance with Article 28, it appears that: 1. the veterinary medicinal product is harmful under the conditions of use stated at the time of the 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 and quantitative composition is not as stated; 2. the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard for the consumer or is insufficiently substantiated; 3. the veterinary medicinal product is offered for sale for a use prohibited under other Community provisions. Authorization shall likewise be refused if the particulars and documents provided by the applicant in accordance with Article 28 are incorrect or if the labelling and package inserts proposed by the applicant are not in accordance with Chapter VII of Directive 81/851/EEC.

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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.