Article 23

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

Each Member State shall ensure that all suspected serious adverse reactions occurring within their territory to a medicinal product authorized in accordance with the provisions of this Regulation which are brought to their attention are recorded and reported immediately to the Agency and the person responsible for placing the medicinal product on the market, and in no case later than 15 days following the receipt of the information. The Agency shall inform the national pharmacovigilance systems.

← 2. · All articles · art_23__para →

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.