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Process to change a registered OTC medicine
V1.2, June 2017
Step 9 - Paying your fees
When you apply to change a registered OTC medicine we will invoice you for the fees that correspond with the application level.
For details of the current fees to change the ARTG entry for a registered OTC medicine 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 fees when you receive the invoice as the application will not be screened (or in the case of notifications, automatically approved) until the fees are processed.
The fees will be assessed during screening (Step 10) and if necessary we will issue a refund, if a waiver or reduction has been requested and granted.
Waiver or reduction of fees for evaluation
In some circumstances, a waiver or reduction of the fees for evaluation may be possible under Regulation 45(4) of the Therapeutic Goods Regulations. If you are eligible:
- include a request and justification in the cover letter of your application and we will make a decision prior to accepting the application for evaluation.
Paying the fees
For information on the available payment methods see the following:
If you are paying the application fees by cheque:
- indicate in the covering letter that payment has been forwarded to TGA Finance
- do not include cheque/credit card details with the submission
- forward payment together with a copy of the relevant invoice by separate post to:
PO Box 100
WODEN ACT 2606