Australia's TGA provides guidance on annual charge exemption

In Australia, the Annual Charge Exemption (ACE) scheme replaced the Therapeutic Goods Administration’s (TGA) low value turnover scheme on July 1, 2015, and companies wishing to claim the exemption for pre-revenue entries must do so between July 1 and 22, 2016.

Under the ACE scheme, products are exempt from the annual charge until they start to generate turnover. Once turnover commences annual charges become payable each year. Sponsors with pre-qualified ACE entries on the Australia Register of Therapeutic Goods (ARTG) will be required to make a declaration, for the first time, in respect of those entries that have not yet started to generate turnover, in order to maintain their exemption from annual charges.

The declarations of zero turnover can only be made between July 1 and 22, 2016. If no declaration is provided, a company’s turnover will be assumed to have commenced in 2015-16 and the annual charge for 2015-16 and 2016-17 will become payable.