(a)

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 establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company and to its representatives is collected, evaluated and collated so that it may be accessed at a single point within the Community;

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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.