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:(a) 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:(i) 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 proprietary 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;(ii) 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 acceptable level of safety;(iii) or that the proprietary medicinal product is essentially similar to a product which has been authorized within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made; this period shall be extended to 10 years in the case of high-technology medicinal products within the meaning of Part A in the Annex to Directive 87/22/EEC (1) or of a medicinal product within the meaning of Part B in the Annex to that Directive for which the procedure laid down in Article 2 thereof has been followed; furthermore, a Member State may also extend this period to 10 years by a single Decision covering all the products marketed on its territory where it considers this necessary in the interest of public health. Member States are at liberty not to apply the abovementioned six-year period beyond the date of expiry of a patent protecting the original product.However, where the proprietary medicinal product is intended for a different therapeutic use from that of the other proprietary medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate pharmacological and toxicological tests and/or of appropriate clinical trials must be provided.(b) In the case of new proprietary medicinal products containing known constituents not hitherto used in combination for therapeutic purposes, the results of pharmacological and toxicological tests and of clinical trials relating to that combination must be provided, but it shall not be necessary to provide references relating to each individual constituent.(1) OJ No L 15, 17. 1. 1987, p. 38.';2. Article 16 is hereby repealed. Member States shall take the measures necessary to comply with this Directive no later than 1 July 1987. They shall forthwith inform the Commission thereof.However, with regard to the Hellenic Republic, the Kingdom of Spain and the Portuguese Republic, the date referred to in the first paragraph shall be replaced by 1 January 1992. This Directive is addressed to the Member States.
Output: Directive