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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 exceptional circumstances and following consultations with the applicant, authorization may be granted subject to certain specific obligations, to be reviewed annually by the Agency. Such exceptional decisions may be adopted for objective and verifiable reasons.

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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.