Article 28

1. An application for authorization for a veterinary medicinal product must be accompanied by the particulars and documents referred to in Articles 5, 5a and 7 of Directive 81/851/EEC. 2. In the case of a veterinary medicinal product containing or consisting of genetically modified organisms within the meaning of Article 2 (1) and (2) of Directive 90/220/EEC, the application must also be accompanied by: a copy of any written consent or consents of the competent authorities to the deliberate release into the environment of the genetically modified organisms for research and development purposes where provided for in Part B of Directive 90/220/EEC, the complete technical dossier supplying the information requested in Annexes II and III to Directive 90/220/EEC and the environmental risk assessment resulting from this information; the results of any investigations performed for the purposes of research or development. Articles 11 to 18 of Directive 90/220/EEC shall not apply to veterinary medicinal products containing or consisting of genetically modified organisms. 3. The application shall also be accompanied by the fee payable to the Agency for the examination of the application. 4. The Agency shall ensure that the opinion of the Committee is given within 210 days of the receipt of a valid application. In the case of a veterinary medicinal product containing or consisting of genetically modified organisms, the opinion of the Committee shall respect the environmental safety requirements laid down by Directive 90/220/EEC to ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release into the environment or placing on the market of genetically modified organisms. During the process of evaluating applications for marketing authorizations for veterinary medicinal products containing or consisting of genetically modified organisms, necessary consultations shall be held by the rapporteur with the bodies set up by the Community or the Member States in accordance with Directive 90/220/EEC. 5. The Commission shall, in consultation with the Agency, the Member States and interested parties, draw up detailed guidance on the form in which applications for authorization are to be presented.

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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.