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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 addition, the person responsible for placing the medicinal product on the market shall be required to maintain detailed records of all suspected adverse reactions occurring within or outside the Community which are reported to him by a health care professional. Unless other requirements have been laid down as a condition of the granting of the marketing authorization by the Community, these records shall be submitted to the Agency and Member States immediately upon request or at least every six months during the first two years following authorization and once a year for the following three years. Thereafter, the records shall be submitted at five-yearly intervals together with the application of renewal of the authorization, or immediately upon request. These records shall be accompanied by a scientific evaluation.

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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.