Article 36

The competent authorities of the Member States shall suspend or withdraw marketing authorization when it is clear that: 1. the veterinary medicinal product proves to be harmful under the conditions of use stated at the time of application for authorization or subsequently, the veterinary medicinal product does not have any therapeutic effect or its qualitative and quantitative composition is not as stated; 2. the recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer; 3. the veterinary medicinal product is offered for sale for a use which is prohibited by 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, consumer or animal health; 4. the information given in the application documents pursuant to Articles 5 and 14 is incorrect; 5. the control tests referred to in Article 35 have not been carried out; 6. 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 Authorization may also be suspended, or withdrawn where it is established that: - the particulars supporting the application, as provided for in Article 5, have not been amended in accordance with the first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.