You are here

OTC new medicines registration process

27 August 2020

Book pagination

Step 8 - Paying your fees

When you apply to register an OTC medicine, we will invoice you for both the application fee and the evaluation fee that corresponds with the application level.

For details of the current fees, go to Schedule of fees and charges

Invoicing the fees

You will automatically receive an invoice when you submit the application.

It is important to pay the application and evaluation fees when you receive the invoice as we do not start screening the application until the fees are processed.

We will assess the fees during screening (see Step 9) and, if necessary, we will issue:

  • an invoice for additional fees if you have paid concurrent (reduced fees) and we determine that you are not eligible for these fees. For example, we may determine that the supporting information is not sufficiently similar to enable simultaneous evaluation.
  • a refund, if we grant your request to waive or reduce the evaluation fee.

Concurrent fees

If you submit an application and you submit additional applications at the same time, you can apply concurrent (reduced) fees to the eligible additional applications which have:

  • the same sponsor
  • the same application level
  • the same active ingredients
  • sufficiently common supporting information to enable simultaneous evaluation.

If you are eligible for concurrent fees, select this option and enter the relevant details when you complete your application (Step 7).

The concurrent fees are listed in the Schedule of fees and charges.

Waive or reduce evaluation fees

  • For applications that are not eligible for concurrent fees, in some circumstances we may be able to waive or reduce the evaluation fee (not the application fee) under Regulation 45(4) of the Therapeutic Goods Regulations 1990.
  • Check these regulations to see if you are eligible for a waiver or reduction in evaluation fees.
  • Once you have checked, if you then think you may be eligible include a request and justification in the cover letter of your application. We will make a decision prior to accepting the application for evaluation.

Paying the fees

For information on fees and the available payment methods see:

Making payments by cheque

If you are paying the application fees by cheque, do:

  • indicate in the covering letter that payment has been forwarded to TGA Finance.
  • forward payment, together with a copy of the relevant invoice, by separate post to:

    TGA Finance
    PO Box 100
    WODEN ACT 2606
    Australia

Do not:

  • include cheque or credit card details with the submission.

Paying additional evaluation fees

If we invoice you for additional evaluation fees these need to be paid in full within 2 months of the date of the invoice or the following will occur:

  • the application will lapse (section 24(2)(a) of the Therapeutic Goods Act 1989) and will not be evaluated
  • you will forfeit the application fee.

Book pagination