Article 28

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

1. Notwithstanding the measures provided for in Article 11 of Directive 65/65/EEC, Member States shall take all appropriate measures to ensure that the supply of the proprietary medicinal product shall be prohibited and the proprietary medicinal product withdrawn from the market if: (a) the proprietary medicinal product proves to be harmful under normal conditions of use; it is lacking in therapeutic efficacy; its qualitative and quantitative composition is not as declared; the controls on the finished product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the authorization referred to in Article 16 has not been fulfilled. 2. The competent authority may limit the prohibition to supply the product, or its withdrawal from the market, to those batches which are the subject of dispute.

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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.