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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

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 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 or placing on the market of genetically modified organisms. During the process of evaluating applications for marketing authorizations for products containing or consisting of genetically modified organisms, necessary consultations will be held by the rapporteur with the bodies set up the Community or the Member States in accordance with Directive 90/220/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.