Market Exclusivity galvanised in Legislation
Bioactive has become the first Therapeutic Goods Administration (TGA) Sponsor to be granted exclusivity within the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2018.
Bioactive has exclusivity for a period of two years for both active and excipient forms of the new ingredient for use in Listed Medicines. This includes complementary medicines, sunscreens and oral health products.
TGA reforms, passed into law by the Federal Senate early in 2018, have made this possible. This reform was introduced to encourage innovation within the Listed Medicines sector and is intended to reward the resources invested by innovators who research and develop new ingredients.
Click on the following link for the TGA Market Exclusivity Fact-sheet: Draft Market Exclusivity Factsheet