Bioequivalence and Bioavailability Forum

Dear Clarc
A generic medicinal product is a product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated. The Marketing Authorisation Applications for generic products have to be submitted in accordance with the Directive 2001/83/EC under Art. 10 (1) and reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted in the Union on the basis of a complete dossier under Art. 8(3) of the Directive 2001/83/EC. The product used as reference product in the bioequivalence study should be part of the global marketing authorisation of the reference medicinal product (as defined in Article 6(1) second subparagraph of Directive 2001/83/EC). So even if two different companies market the same product under two different names it should be possible to establish bioequivalence with only one study using one reference (DCP or MR procedure). However, the decision which of the both reference products should be taken should be done by the sponsor and not the CRO.
I hope this helps.
Kind regards
Dan