The annual charge exemption (ACE) scheme replaced the Therapeutic Goods Administration’s (TGA) low value turnover scheme on 1 July 2015 and companies wishing to claim the exemption for pre-revenue entries must do so between 1 and 22 July 2016.
Under the Annual Charge Exemption (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 1 and 22 July 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.
The TGA will be issuing invoices for annual charges for 2016-17 in the first week of August, which will be due for payment by 15 September 2016.
Sponsors with pre-qualified ACE entries on the ARTG have been provided with a list of their pre-qualified entries, which is also available through the TGA Business Services (TBS) portal.
If you wish to retain your exemption for 2016-17, you must declare which of your products with the pre-qualified ACE status had not yet started generating turnover. The declaration will confirm ACE for those products for 2015-16 and pre-qualified them for ACE status for 2016-17.
Declarations can be made by logging into the TBS portal, or if you do not have access to TBS, by submitting a ‘Declaration of Low Value ($0) Turnover’ form which will be available on the TGA website before 1 July 2016.