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Changing the sponsor of therapeutic goods

Version 4.0, October 2020

8 October 2020

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Change of sponsor name

You also need to tell us where you as a sponsor (whether an individual or a company):

  • change your name, or
  • if a company, you amalgamate with another company (and as a result change your name).

This does not result in a change of sponsor, but it does require us to update any relevant ARTG entries to ensure they remain accurate.

This is done within our secure online business portal, TBS. If you have TBS access, you can make changes to the client name using your user account details.

If you do not have TBS access, either:

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).

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