Article 2

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 definitions laid down in Article 1 of Directive 65/65/EEC and those laid down in Article 1 (2) of Directive 81/851/EEC shall apply for the purposes of this Regulation. The person responsible for placing the medicinal products covered by this Regulation on the market must be established in 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.