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Changing the sponsor of therapeutic goods

11 July 2019

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Change of sponsorship after death, bankruptcy or winding up

Who becomes the new sponsor?

Following the death or bankruptcy of a person, or winding up of a company, the new sponsor is the person (or company) described in the table below. This person becomes responsible for any relevant ARTG entries, regardless of whether we have been notified of the event.

The following table outlines who is the new sponsor for particular events.

Sponsor event New sponsor
Death Legal representative of the sponsor who died
Bankruptcy Trustee in bankruptcy of the sponsor that has become bankrupt
Winding up of body corporate Liquidator of the body corporate

Requirements for new sponsors

We urge new sponsors to advise us of a change of sponsorship as soon as possible. This ensures we know who they are if we need information from them or any action needs to be taken in relation to the products in the ARTG.

Under regulations 10AB, 10F and 10H, the new sponsor must:

  • notify us within 3 months of the event (even if 3 months has passed, notify us as soon as possible in any event)
  • provide us with evidence of the relevant event (preferably by completing and lodging a notification form)

See also: Obligations of new sponsor

How do I notify the TGA?

Please use the following form to notify the TGA: Notification: transfer of sponsorship following death, bankruptcy or winding up

You can include ARTG entries for different therapeutic good types in the one form (e.g. medicines, medical devices, etc.), provided the relevant change comes from the same event (e.g. bankruptcy).

When you complete the form, ensure that you:

  • make the relevant declarations about the nature of the relevant event, including the date on which it occurred
  • include a list of the relevant therapeutic goods (for each, ensure you include its ARTG entry number, and the type of therapeutic good).

Who signs the form?

The person to sign the form must be either:

  • the new sponsor (i.e. the legal representative, trustee in bankruptcy or the liquidator); or
  • a person who has the authority of the new sponsor to sign the form (e.g. a partner of a law or accountancy firm, or a person authorised to sign the form on that person's behalf).

Please note

If you choose not to use the form, you must:

  • identify which regulation (10AB, 10F or 10H) you are notifying us under, and
  • provide sufficient documentary material to verify the event stated in the notification (e.g. bankruptcy).

Important

We may ask you, as the person giving us the notification to provide more information before we make updates to the ARTG. This may include additional evidence about the event that triggered the transfer (or its date), and the additional information required may depend on the circumstances of the particular case.

You should be aware that, under the Criminal Code, it is an offence to:

  • knowingly provide information to the Commonwealth (including the TGA) that is false or misleading in a material particular, or
  • omit any information, without which the information is misleading in a material particular.

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