lexiara

art_4__para

In order to examine the application submitted in accordance with Article 4 of Directive 65/65/EEC, the competent authorities of the Member States: (a) must verify whether the particulars submitted in support of the application comply with the said Article 4 and examine whether the conditions for issuing an authorization to place proprietary medicinal products on the market (marketing authorization) are complied with;

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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.