As June 30 approaches in the depths of the Australian Winter, manufacturers should do a little early Spring cleaning. Any registration which are no longer needed should be cancelled – or you will be liable for another Annual Fee.
TGA is a fully cost recovered agency. It charges fees to manufacturers and sponsors which cover the cost of its operations. That includes an annual fee levied on every product registration – i.e. every medical device or medicine entry in the Australian Register of Therapeutic Goods (ARTG). IVDs are currently exempt.
If you have ARTG registrations which are no longer used – because the product is discontinued and no longer supplied, then be sure to cancel the registration. This MUST be done before the strict deadline of 5:00 p.m. on 30 June Australian Eastern Time. Otherwise you will be up for another Annual charge – which could be up to $1,175 for a medical device or 6,725 for a biological medicine.
See https://www.tga.gov.au/form/request-cancel-artg-entry for the TGA forms and notification process.
Time to clean house…
Need help with TGA regulatory compliance? If you’d like to know more about the TGA requirements or support for regulatory submissions and compliance in Australia contact our Sydney office – we would be pleased to step you through how this all works. Call +61 (0)2 9906 2984 or email firstname.lastname@example.org.