Data exclusivity for new combinations

Under the old TPA, the marketing authorisation holder of new combinations of two known active substances (“known API with innovation”, whereby the combination is the innovation) was granted a data exclusivity period of 3 years for the combination product. Under the new act, a combination is only subject to a three-year data exclusivity period if one of the conditions listed in Art. 11b TPA is also applicable. The list includes: a new indication, a new method of administration, a new dosage form, or a new dosage.