No L 15/36 Official Journal of the European Communities 17. 1. 87 COUNCIL DIRECTIVE ’ of 22 December 1986 amending Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (87/21/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission ('), Having regard to the opinion of the European Parli- ament (%), ‘ Having regard to the opinion of the Economic and Social Commiittee (%), Whereas point 8 of the second paragraph of Article 4 of Council Directive 65/65/EEC (*), as last amended by Directive 83/570/EEC (%), provides that various types of proof of the safety and efficacy of a proprietary medicinal product may be put forward in an application for marke- ting authorization depending upon the objective situation of the proprietary medicinal product in question ; Whereas experience has shown that it is advisable to stipulate more precisely the cases in which the results of pharmacological and toxicological tests or clinical trials do not have to be provided with a view to obtaining authorization for a proprietary medicinal product which is essentially similar to an authorized product, while ensu- ring that innovative firms are not placed at a disadvan- tage ; Whereas additional details were provided in respect of the application of the abovementioned provision by Council Directive 75/318/EEC of 20 May 1975 on the approxima- tion of the laws of the Member States relating to analy- tical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medi- cinal products (), as last amended by Directive 87/19/EEC () ; Whereas, however, there are reasons of public policy for not conducting repetitive tests on humans or animals without over-riding cause ; Whereas it is also advisable to make the packaging of certain proprietary medicinal products, particularly sought after by drug addicts, less distinctive by removing the obligation to place a special mark on the outer packaging and the container of proprietary medicinal products clas- sified as narcotics; OJ No C 293, 5. 11. 1984, p. 8. OJ No C 36, 17. 2. 1986, p. 152. OJ No C 160, 1. 7. 1985, p. 18. OJ No 22, 9. 2. 1965, p. 369/65. OJ No L 332, 28. 11. 1983, p. 1. OJ No L 147, 9. 6. 1975, lp 1. () See page 31 of this Official Journal. Whereas the Hellenic Republic, the Kingdom of Spain and the Portuguese Republic should have additional time to transpose this Directive so that they may as a priority complete the review of old proprietary medicinal products as provided for in Article 39 of the 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 (%) as last amended by Directive 83/570/EEC, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 65/65/EEC is hereby amended as follows : 1. Point 8 of the second paragraph of Article 4 shall be replaced by the following text : ‘8. Results of : — physico-chemical, biological or microbiological tests, ' — pharmacological and toxicological tests, — clinical trials. However, and without prejudice to the law relating to the protection of industrial and commercial property : (@) The applicant shall not be required to provide the results of pharmacological and toxicological tests or the results of clinical trials if he can demonstrate : ' ' (1) either that the proprietary medicinal product is essentially similar to a product authorized in the country concerned by the application and that the person responsible for the marketing of the original proprie- tary medicinal product has consented to the pharmacological, toxicological or clinical references contained in the file on the original proprietary medicinal product being used for the purpose of examining the application in question ; (i) or by detailed references to published scientific literature presented in accordance with the second paragraph of Article .1 of Directive 75/318/EEC that the constituent or constituents of the proprietary medicinal product have a well established medicinal use, with recognized efficacy and an accep- table level of safety; () OJ No L 147, 9. 6. 1975, p. 13.