Information & notices about TGA fees & payments

Online payment portal

Payments to the TGA are made through an online payment portal: https://www.bpoint.com.au/payments/TGA.

Where necessary, payments can be made without an invoice. To do this, please enter the biller code (this is the application type and can be selected from the options in the drop down list), client ID and payment amount.

You can make the following payments online without an invoice:

• clinical trial notification fee
• exemption under section 14
• variation to a medicine or device

Once the payment information has been entered, you have the option to request that a tax invoice/receipt be emailed directly to you.

When you have finalised your payment, a new page will open confirming that your payment has been successful. You can also request that a copy of this payment confirmation be emailed to you.

General information & notices

• Changes to fees and charges effective 1 July 2018
  20 June 2018: Important information regarding fees and charges applicable from 1 July 2018
• Australian Government funding for biologicals
  Provides guidance on applying for Australian Government funding for Australian publicly funded facilities and not-for-profit hospital supply units for biologicals
• Refunds
  With few exceptions, regulatory fees and charges are non-refundable and non-transferable

Annual charges

• Annual charges
  Annual charges apply to all product entries on the Australian Register of Therapeutic Goods
• Annual Charge Exemption Scheme
  The Annual Charge Exemption (ACE) scheme allows for the exemption of annual charges until a product first generates turnover
• Annual charge invoices
  Invoices for annual charges will be issued in early August
• Cancellation of a therapeutic good for non-payment of an annual charge
  Therapeutic products entered on the Australian Register of Therapeutic Goods may be cancelled for non-payment of an annual charge
• Regulation impact statement - Review of the low value turnover exemption scheme
  Documents the proposal on which we consulted and the new scheme to replace the LVT scheme

Manufacturers

• Annual charges for manufacturing licences
  Holders of a licence to manufacture therapeutic goods are required to pay an annual licence charge
• Low turnover manufacturers
  Annual charges for a licence to manufacture a therapeutic good may be reduced by 50% if the wholesale turnover of that good is below a prescribed level
• Revoking manufacturing licences for not paying annual fees
  We can revoke a manufacturing licence if the annual charge is not paid on time