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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

the obligation referred to in the second paragraph of Article 12 has not been fulfilled. The veterinary medicinal product shall be deemed to have no therapeutic effect if it is established that it does not produce therapeutic results in the species of animal for which the treatment is intended. Authorization may also be suspended, or withdrawn where it is established that: - the particulars supporting the application, as provided for in Article 5, have not been amended in accordance with the first and third paragraphs of Article 14, any new information as referred to in the second paragraph of Article 14 has not been communicated to the competent authorities.

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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.