2Council 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 (OJ, English Special Edition 1965-1966(I), p. 20), as amended by Council Directive 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22) (‘Directive 65/65’), was repealed by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67). Article 4 of Directive 65/65 provided:‘For the purpose of obtaining the marketing authorisation provided for in Article 3, the person responsible for marketing shall lodge an application with the competent authority of the Member State....The application shall be accompanied by the following particulars and documents:...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:...(iii) that the medicinal product is essentially similar to a medicinal product which has been authorised 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. … a Member State may also extend this period to 10 years by a single Decision covering all the medicinal products marketed on its territory where it considers this necessary in the interest of public health. …...’
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