Article 6

Where a leaflet is enclosed with the packaging of a proprietary medicinal product Member States shall take all appropriate measures to ensure that it applies to the product in question only. All the information given in the leaflet must be in accordance with the particulars and documents supplied pursuant to Article 4 of Directive 65/65/EEC and must be approved by the competent authorities. The leaflet must include at least the following information: (a) name and domicile or corporate name and domicile or registered place of business of the person responsible for marketing the product and, where applicable, of the manufacturer; Member State may require that a leaflet be included with the packaging. name and qualitative and quantitative particulars of the product in terms of its active ingredients. The international non-proprietary names recommended by the World Health Organization should be used where such names exist; in the absence of a decision to the contrary by the competent authorities: - therapeutic indications, contra-indications, side effects and special precautions for use. Information and decisions under the first and second indents shall take into account the results of the clinical trials and pharmacological tests provided for in point 8 of Article 4, second paragraph, of Directive 65/65/EEC and in the case of the information referred to under the second indent, of experience acquired in use after marketing; directions for use of the product (method of administration, duration of treatment if this should be limited, normal dosage); special storage precautions, where applicable. Other information shall be clearly separate from that referred to above.

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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.