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.
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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.