Article 4

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

1. In order to obtain the authorization referred to in Article 3, the person responsible for placing a medicinal product on the market shall submit an application to the European Agency for the Evaluation of Medicinal Products, hereinafter referred to as 'the Agency', set up under Title IV. 2. The Community shall issue and supervise marketing authorizations for medicinal products for human use in accordance with Title II. 3. The Community shall issue and supervise marketing authorizations for veterinary medicinal products in accordance with Title III. TITLE II AUTHORIZATION AND SUPERVISION OF MEDICINAL PRODUCTS FOR HUMAN USE CHAPTER 1 Submission and examination of applications - authorizations - renewal of authorization

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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.