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2.

The opinion of the Committee shall deal with the compliance of the proprietary medicinal product with the conditions set out in Article 5 of Directive 65/65/EEC. The Committee shall forthwith inform the Member States concerned of its opinion or, in the event of a divergence, of the opinions of its members.

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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.