abriged application

Abstract

EC: “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 … and that the person responsible for the marketing of the original product has consented to the … references contained in the file being used … (ii) or by detailed references to published scientific literature … (iii) or that the product is essentially similar to a product which has been authorized within the Community … for not less than 6 (10) years and is marketed in the Member State for which the application is made …; … where the … product is intended for a different therapeutic use from that of the other products marketed or is to be administered by different routes or doses, the results of appropriate pharmacological and toxicological tests and/ or clinical trials must be provided”; → see also hybrid procedure.