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Changing the sponsor of therapeutic goods

11 July 2019

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What you need to do

When you become the new sponsor of an ARTG entry or entries, you:

  • must inform us within 3 months of the event, and
  • may need to provide evidence of the transfer/assignment.

When you, as the sponsor of therapeutic goods in an ARTG entry or ARTG entries:

  • change your name or,
  • as a company, amalgamate with another company and, as a result, change the company’s name,

you:

  • must inform us within 3 months of the event, and
  • may need to provide evidence of the change of name.

Information about when evidence is required (including the type of evidence), can be found in the sections under 'How to notify us'.

How to notify us

Depending on the circumstances, a different form is used. The following pages explain each of these, and provide information about the relevant form:

Submitting the form

Completed forms should be sent to the TGA TBS helpdesk:

Fees

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).

If you don't have TBS access

See TGA Business services: getting started with the TGA for information on how to apply for access.

Relevant legislation

The Therapeutic Goods Regulations 1990 provides the basis for transfer of sponsorship:

  • Listed and registered therapeutic goods - regulation 10A (sponsor transfer)
  • Medical devices - regulation 10F (sponsor transfer)
  • Biologicals - regulation 10H (sponsor transfer).

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