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Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products · European Union

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.

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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.