Manufacturers who have TGA registrations but haven’t yet started sales can claim relief from TGA annual charges – but only if they act very quickly.
Through the TGA’s Annual Charge Exemption (ACE) Scheme, products which have generated zero turnover may be exempt from incurring the annual charges. This applies only to products registered within the previous year as well as those older products for which declarations of zero turnover have been made in each year since its initial listing. This scheme will be available for all therapeutic goods, inclusive of IVDs.
It is important to note that inclusion in this scheme is through a self-declaration; if no declaration is made, the TGA will assume that turnover has been generated and the entry will be excluded from the scheme for the current year and any future year regardless of whether any money has been made.
Declarations can be made between July 1 and 22, 2018 through the TGA’s online eBS portal or via a physical form. See the TGA’s Annual Charge Exemption page for further details of the scheme.
Below is a table of important upcoming dates. For clients of Brandwood Biomedical, we’ll be reaching out individually to ensure these are covered.
|22 July 2018||Deadline for providing declarations in relation to zero turnover to keep an existing annual charge exemption (to avoid cancellation of exemptions – for the life of the product)|
|Early August 2018||2018-19 annual charges invoices are generated|
|15 September 2018||Final date for payment of 2018-19 annual charges (to avoid cancellation of ARTG entries)|
|1 October 2018||Annual reports due
– Class III
– Implantable Class IIb
– Class 4 IVDs