28.11.83 Official Journal of the European Communities No L 332/1 I1 (Acts whose publication is not obligatory) COUNCIL COUNCIL DIRECTIVE of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (83/570/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, - - Having régard to the proposal from the Commission, Having regard to the opinion of the European Parliament (%), Having regard to the opinion of the Economic and Social Committee (2), Whereas the Directives on the approximation of the laws relating to proprietary medi- cinal products must be adapted to scientific progress and take account of the experi- ence obtained since their adoption; Whereas Article 15 (2) of 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) provides that the Commission shall sub- mit to the Council a proposal containing appropriate measures leading towards the abolition of any remaining barriers to the free mhovement of proprietary medicinal products, not later than four years after the entry into force of the abovementioned Directive; Whereas it is necessary from the point of view of public health and the free movement of medicinal products for the competent. authorities to have at their disposal all useful information on authorized proprietary products, based in particular on summaries, adopted in the other Member States, of the characteristics of products; Whereas it is necessary to specify certain provisions relating to physicochemical, bio- logical or microbiological tests on proprietary medicinal products and to introduce the principle of bio-availability and mutagenesis tests in order to safeguard public health; (') OJ NoC287,9.11. 1981, p. 127. () OJ No C 189, 30.7. 1981, p. 39. () OJ NoL147,9.6. 1975, p. 13.