5Point 9 of the second paragraph of Article 4 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended by Council Directive 83/570/EEC of 26 October 1983 (OJ 1983 L 332, p. 1) and Council Directive 89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11), requires that the application for authorisation be accompanied by ‘[a] summary, in accordance with Article 4a, of the product characteristics, one or more specimens or mockups of the sales presentation of the medicinal product, together with a package leaflet where one is to be enclosed’.
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