You also need to tell us when you change your name as a sponsor whether as an individual or a company.
You are not required to register as a new sponsor, but we need to update any relevant entries on the Australian Register of Therapeutic Goods (ARTG) to ensure they remain accurate.
Please notify us by contacting the TGA Business Services helpdesk (TBS) on 1800 010 624 or at ebs@tga.gov.au
If you are a Manufacturer as well as a Sponsor
If you are also an active manufacturer of ARTG entries, please direct your request to update your organisation name to the relevant regulatory area:
- for listed or prescription medicines, please contact GMP@health.gov.au
- for medical devices, please contact devices@tga.gov.au
Changing sponsor details in the Product Information and labels
When there is a change in sponsor name and details, you must also apply to change the details in the Product Information (PI) and labels.
For more information refer to Changing sponsor details in Product Information (PI) and labels of prescription medicines.
If the ABN or ACN is also changing
If changing the business name involves changing the Australian Business Number (ABN) or Australian Company Number (ACN), this constitutes forming a new business entity and therefore a change of sponsorship.
This is considered to be a transfer of business, and therefore needs to follow the process for a Change in business ownership.
Relevant legislation
The Therapeutic Goods Regulations 1990 provides the basis for change of name:
- Listed and registered therapeutic goods - regulation 10AC (change of name)
- Medical devices - regulation 10FA (change of name)
- Biologicals - regulation 10HA (change of name).