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Once your application has been submitted

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ARGCM Part D: Registered complementary medicines

29 October 2017

Invoice and payment

Once you have submitted your application, an invoice will be raised comprised of:

For options on how to make your payment, refer to Payment options.

Your application will not proceed until both the application fee and base evaluation fees have been paid.

Pre-evaluation assessment

We will review your application dossier to determine:

  • if the dossier is acceptable for evaluation, and
  • that the appropriate evaluation fee has been paid.

We will start the evaluation process once we confirm the submitted information is satisfactory, and the evaluation fee has been paid in full.

We will notify you (in writing) if your application has been accepted (or not) for evaluation.

Total evaluation fee

We will determine the total evaluation fee for your application.

In some cases, this may exceed the base evaluation fee initially invoiced, for example:

If your application dossier consists of clinical and toxicological data that exceeds the base evaluation fee page count (that is, 51 pages or more) then you will be invoiced for an additional supplementary fee once a pre-evaluation assessment has been performed by the TGA.

Requesting a reduction of the 'base' evaluation fee

In certain circumstances, you may have adequate justification to request a reduction of your evaluation fee under Regulation 45 of the Therapeutic Goods Regulations 1990.

If so, attach this request to your TGA Business Services application (or include your request in your covering letter).

If successful, the base evaluation fee will be adjusted and a refund may be provided.