8In addition to the documentation which they were required to submit under the abridged procedure, Synthon and Genthon supplied results from selected pharmacological and toxicological tests on animals of the type referred to in the Annex to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (OJ 1975 L 147, p. 1), as amended by Commission Directive 91/507/EEC of 19 July 1991 (OJ 1991 L 270, p. 32; ‘Directive 75/318’). The Lægemiddelstyrelsen subsequently requested further information.
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