lexiara

Article 3

In the event of Article 2 of this Directive not being complied with, Article 5, second paragraph, of Directive 65/65/EEC shall apply. CHAPTER II Examination of the application for authorization to place proprietary medical products on the market

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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.