31987Y0707(01)

COUNCIL CONCLUSIONS of 15 May 1987 on improvement in the use of proprietary medicinal products by consumers (87/C 178/02)

THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Whereas 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 (1), as last amended by Directive 87/21/EEC (2), lays down rules for the marketing of proprietary medicinal products intended for human use; Whereas 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 (3) contains provisions on examination of the application for authorization to place on the market and on the package leaflet in particular; Whereas the system for leaflets accompanying proprietary medicinal products, for human consumption, on the market in the Community should be improved, 1. REQUESTS the Commission and the Member States to begin studying now the possibility of making more systematic the use, and more legible and intelligible the content, of the consumer information leaflets, referred to in Article 6 of Directive 75/319/EEC, accompanying proprietary medicinal products, in particular 'over the counter' products, marketed on the territory of the Community the purpose being to:- encourage the secure and appropriate use of proprietary medicinal products and in particular completion of a full course of treatment by supplementing the instructions given by doctors and pharmacists with clearly worded written information;-satisfy the consumer's wish to be properly informed; 2.REQUESTS the Commission and the Member States to-exchange experience within the relevant Community bodies, where appropriate through pilot projects;-ensure that the circles concerned are consulted and made more aware of the problem during the preparatory discussions;3.in conclusion, REQUESTS the Commission to submit a report to the Council containing the conclusions of the studies provided for in point 1 and the experience and consultation provided for in point 2 accompanied, if appropriate, by suitable proposals, concerning the information for doctors and patients, envisaged in its White Paper on the completion of the internal market. (1) OJ No 22, 9. 2. 1965, p. 369/65.

(2) OJ No L 15, 17. 1. 1987, p. 36.

(3) OJ No L 147, 9. 6. 1975, p. 13.