TGA Approval – Hans Rudolph

[Grace Madden]

Kate Hardaker from Concord Repatriation General Hospital has kindly shared the process for how their Laboratory sought approval for medical use of non-TGA listed items (Shunt, AST and EVH tests).

Step 1: Obtain Local Ethics Approval

1. Prepare the required documentation for ethics approval.
2. Submit an application for your laboratory medical director to become an ‘Authorised prescriber of unapproved products for multiple patients’ according to your local ethics process.
3. Include:
   1. The ethics approval letter (template provided by Kate)
   2. Supporting documents (as per local requirements).
4. Kate’s team received approval with ~24hours.

Step 2: Apply to the TGA for Authorised Prescriber Status

1. Use the local ethics approval to apply to the Therapeutic Goods Administration (TGA). See the application form
2. The medical director submits the application via the TGA website.
3. Provide all necessary information and supporting documents for the application (template provided by Kate).
4. Kate’s team received approval in about two weeks.

Step 3: Ongoing Reporting to the TGA

1. Report to the TGA twice a year on usage of the approved devices.
2. For example, collect statistics on:
   1. Shunt tests
   2. AST tests
   3. EVH tests

Step 4: Renewal of Approval

1. The initial approval is valid for 2 years.
2. Before expiry:
   1. Reapply for ethics approval.
   2. Reapply to the TGA for continued authorised prescriber status.

[Attaul]

Thanks Kate and Grace. This process is similar to what we did at the Princess Alexandra Hospital. Please note that the ethics application process will differ slightly depending on the local ethics committee/Board requirements.

[Aqeela Dawoodjee]

Hi Kate. Thank you so much for sharing! Were you required to complete the approval forms for every piece of equipment in the setup that is not TGA approved? I am assuming the answer is Yes but no harm in double checking.

• This reply was modified 1 month, 3 weeks ago by Aqeela Dawoodjee.

[Kate]

Thank you for sharing Grace. I hope the above works for those that follow the process. Please reach out if you need any help, I am happy to assist.

[Author]

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