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, 2017 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.
Need help with TGA regulatory compliance? If you’d like to know more about the TGA’s annual charges and how they apply to your products or if you require help determining the eligibility of your products for the TGA’s ACE Scheme, contact our Sydney office – we would be pleased to step you through how this all works. Call us on +61 2 9906 2984 or email email@example.com.