No L 113/8 Official Journal of the European Communities 30. 4. 92 COUNCIL DIRECTIVE 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas measures aimed a progressively establishing the internal market over a period expiring on 31 December 1992 need to be taken; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulations or administrative action relating to medicinal products (4), as last amended by Directive 89/343/EEC (), establishes a list of particulars to be given on the immediate packaging and the outer packaging of medicinal products for human use; whereas this list should be supplemented and details given of how labelling is to be presented; 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 (6), as last amended by Directive 89/381/EEC (7), establishes a non-exhaustive list of particulars to be included in package leaflets; whereas this list should be supplemented and details given of how such leaflets are to be presented; Whereas the provisions on labelling and on package leaflets should be brought together in a single text; (1) OJ No C 58, 8. 3. 1990, p. 21. (2) OJ No C 183, 15. 7. 1991, p. 213. (3) OJ No C 225, 10. 9. 1990, p. 24. (%) OJ No 22, 9. 2. 1965, p. 369/65. (5) O] No L 142, 25. 5. 1989, p. 14. (6) OJ No L 147, 9. 6. 1975, p. 13. (7) O] No L 81, 28. 6. 1989, p. 44. Whereas the provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information; : Whereas the marketing of medicinal products whose labelling and package leaflets comply with this Directive should not be prohibited or impeded on grounds connected with the labelling or package leaflet, HAS ADOPTED THIS DIRECTIVE: CHAPTER | Scope and definitions Article 1 1. This Directive deals with the labelling of medicinal products for human use and leaflets inserted in packages of such products, to which Chapters II, III, IV and V of Directive 65/65/EEC apply. 2. For the purposes of this Directive: — name of the medicinal product means the name given to a medicinal product, which may be either an invented name or a common or scientific name, together with a trade mark or the name of the manufacturer; the invented name shall not be liable to confusion with the common name, — common name means the international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name, — strength of the medicinal product means the content of the active ingredient expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form, — immediate packaging means the container or other form of packaging immediately in contact with the medicinal product, — outer packaging means the packaging into which is placed the immediate packaging,