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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

The Commission in consultation with the Agency, Member States, and interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports. The Agency, in consultation with the Member States and the Commission, shall set up a data-processing network for the rapid transmission of data between the competent Community authorities in the event of an alert relating to faulty manufacture, serious adverse reactions and other pharmacovigilance data regarding medicinal products marketed in the Community.

National law under this provision

1 national measure recorded under this provision, in 1 form — sign in to view the analysis.

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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.