preamble_25

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

Whereas risks to the environment may be associated with medicinal products containing or consisting of genetically modified organisms; whereas therefore it is necessary to provide for an environmental risk assessment of such products similar to that provided for by Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (10), together with the assessment of the quality, safety and efficacy of the product concerned within a single Community procedure;

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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.