preamble_14

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

Whereas, moreover, the provisions of this Directive and of that of Directive 65/65/EEC which relate to proprietary medicinal products, although appropriate, are inadequate for vaccines, toxins and serums, proprietary medicinal products based on human blood or blood constituents, proprietary medicinal products based on radio-active isotopes and homeopathic proprietary medicinal products ; whereas the application thereof should consequently not be imposed at the present time in respect of such proprietary medicinal products;

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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.