Article 4
1. Applications for the marketing authorisations referred to in Article 3 shall be submitted to the Agency. 2. The Community shall grant and supervise marketing authorisations for medicinal products for human use in accordance with Title II. 3. The Community shall grant and supervise marketing authorisations for veterinary medicinal products in accordance with Title III. TITLE II AUTHORISATION AND SUPERVISION OF MEDICINAL PRODUCTS FOR HUMAN USE Chapter 1 Submission and examination of applications - Authorisations
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Source: EUR-Lex (Cellar) · retrieved 2026-11-03 · Text as adopted (Official Journal); later amendments are not incorporated in this text.