13 of Directive 2001/ 82/ EC as amended, in which it is stated that “ By way of derogation from point (j) of the first subparagraph of Article 12 (3), 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 the safety and residue tests or of the preclinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorized under Article 5 for not less than eight years in a Member State or the Community .”