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9.

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

One or more specimens or mock-ups of the sales presentation of the proprietary product, together with a package leaflet where one is to be enclosed.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.