Small and Medium-sized Enterprises

The revision of the pharma legislation was adopted in March 2004. It foresees the need to pay special attention to micro, small and medium-sized enterprises (SMEs). Article 70(2) of Regulation (EC) No 726/2004 foresees specific provisions establishing the circumstances in which SMEs may pay reduced fees, defer payment of the fee, or receive administrative assistance. This initiative will provide a powerful legal instrument to help small players in Europe.