(c)

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

where applicable, to state the grounds for using the published references mentioned in point 8 (a) and (b) of Article 4, second paragraph, of Directive 65/65/EEC under the conditions set out in Directive 75/318/EEC.

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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.