Changing the sponsor of therapeutic goods

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17 August 2016

Change in business or product ownership

Who becomes the new sponsor?

Following a change in business or product ownership, 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 change.

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

Sponsor event New sponsor

Transfer or assignment by a person of:

  • the business to which listed or registered therapeutic goods relate, or
  • the person's interest in the therapeutic goods, and

who also agrees to transfer or assign the registration or listing in the Register of the goods.

Person to whom the business or interest is transferred or assigned.

Transfer or assignment by a person of:

  • the business to which a kind of medical devices relates, or
  • the person's interest in the kind of medical device, and

who also agrees to transfer or assign the inclusion of the medical devices in the Register.

Person to whom the business or interest is transferred or assigned.

Transfer or assignment by a person of:

  • the business to which a biological relates, or
  • the person's interest in the biological, and

who also agrees to transfer or assign the inclusion of the biological in the Register.

Person to whom the business or interest is transferred or assigned.

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.

Under regulations 10AB, 10F, or 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), and
  • 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 TGA?

Please use the following form to notify the TGA: Notification: transfer of sponsorship following transfer/assignment of business or interest in therapeutic good.

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 transfer or sale of business.

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, and
  • 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?

Both the new and former sponsor should sign this form, for example:

  • New sponsor
    • the new owner, managing director, etc.; or
    • a person who is authorised to sign the form on behalf of the new sponsor.
  • Former sponsor
    • the previous owner, managing director, etc.; or
    • a person who is authorised to sign on behalf of the former sponsor.

This provides us with additional evidence (as required by the relevant regulations) to establish that the transfer or assignment has occurred.

If the former sponsor can't complete the form

In exceptional circumstances, we will accept a notification that has not been signed by the former sponsor. If you are a new sponsor and are unable to get the signature of the old sponsor, please contact us.

In such a case we may require the new sponsor to provide both:

  • an explanation for why it is not possible for the former sponsor to complete the form; and
  • additional evidence to verify that the sponsor transfer has taken place.

We will consider contacting the former sponsor if there are any doubts about the status of the relevant entries in such a case.

Contact the TGA Business Services (TBS) Helpdesk of the TGA at sponsortransfers@tga.gov.au or 1800 010 624.

Please note

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

  • you identify which regulation (10AB, 10F or 10H) you are notifying us under, and
  • provide sufficient documentary evidence to verify the event stated in the notification (e.g. sale of the business to the new sponsor)

Important

We may ask the person giving us the notification to provide more information before updating the entries in 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.

What should former sponsors do?

If you are proposing to transfer the sponsorship of goods in the ARTG, for instance through the sale of your business, you may be asked by the new sponsor to sign the TGA notification form in relation to the transfer.

To help ensure that the ARTG is updated as soon as possible, you may consider requiring the purchaser (i.e. the prospective new sponsor) as part of the contractual obligations to:

  • provide you with a notification form to sign within X days of the sale; and
  • provide it to us as soon as possible after the sale takes place.

This will help to ensure:

  • we do not unnecessarily involve you (as the former sponsor) in any regulatory matters that may occur after the sale takes place, and
  • there is minimal delay between the change in sponsorship, and updating the ARTG with the new sponsors' details.

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