Article 36

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

The following shall be substituted for Article 11, second paragraph, of Directive 65/65/EEC: "An authorization shall also be suspended or revoked where the particulars supporting the application as provided for in Article 4 are found to be incorrect, or when the controls referred to in Article 8 of this Directive or in Article 27 of the Second Council Directive 75/319/EEC (1) of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products have not been carried out." The following footnote shall be added:

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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.