Orphan Drug Exemption Scheme

An Orphan Drug Fee Exemption scheme is in place for medicinal products holding a central marketing authorisation issued by the European Medicines Agency and that are also included in the Community Register of Orphan Medicinal Products. The difference in fees due to the inclusion of these medicinal products in MaMVO’s fee calculation must be more than 50% of the combined turnover from the medicinal products in Malta (25% if the authorisation holder is listed as a SME in the European Medicines Agency SME Register). Turnover figures are self-certified, but MaMVO reserves the right to request supporting evidence and/or audit the declared turnover. Any approved exclusion of medicinal products from a fee computation will be valid for one financial year only, and renewed applications must be made in subsequent years; these will be considered independently of previous decisions.