Another special incentive is access to a centralised procedure bestowing marketing authorisation upon the specific sponsor within each member state immediately under Regulation (EC) No 726/2004,5.Since it’s inception the EU Regulation on orphan medicinal products 126 Orphan Drugs have been accepted and 1,329 designations for Orphan Status. In order to take advantage of the aforementioned incentives a designation must be approved which means a drug must be deemed safe and effective with supported scientific data in the form of clinical trials or in vitro data to back up this statement. Applications are ratified by the committee for orphan medicinal products and were accepted by article 3(a) and on grounds of insufficient financial returns. The
Another special incentive is access to a centralised procedure bestowing marketing authorisation upon the specific sponsor within each member state immediately under Regulation (EC) No 726/2004,5.Since it’s inception the EU Regulation on orphan medicinal products 126 Orphan Drugs have been accepted and 1,329 designations for Orphan Status. In order to take advantage of the aforementioned incentives a designation must be approved which means a drug must be deemed safe and effective with supported scientific data in the form of clinical trials or in vitro data to back up this statement. Applications are ratified by the committee for orphan medicinal products and were accepted by article 3(a) and on grounds of insufficient financial returns. The