Post: TBS helpdesk, TGA, PO Box 100, Woden ACT 2606, Australia
There is no fee for notifying us about a change of sponsorship or change of name. However if as a result of either of those, the name of the therapeutic goods (such as a medicine) is also to be changed, an application for a new approval for the medicine may be required.
Fees are payable if the change requires any additional updates to ARTG entries. For example:
a transfer which includes a prescription medicine will usually require:
a transfer which includes a medical device may require:
provision to the TGA of Manufacturers' Evidence
What happens after notification?
Once we receive a fully completed and signed notification form (including additional information if required), or other acceptable form of notification, we will update the relevant ARTG entries, usually within 10 working days.
Approximately 24 hours after the change(s) are completed, new ARTG certificates for the entries will be available to the new sponsor through our online portal - TGA Business Services (TBS).
Listed and registered therapeutic goods - regulation 10A (sponsor transfer)
Medical devices - regulation 10F (sponsor transfer)
Biologicals - regulation 10H (sponsor transfer).
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.