Online applications for registered complementary medicines
This new guidance replaces Guidance for new registered complementary medicine applications v2.0 (December 2015).
This guidance is for registered complementary medicine applications, and explains the new online application form on the TGA Business Services (TBS) website.
Which applications use the new online form?
Applications for:
- new registered complementary medicines (new ARTG entry)
- changes to registered complementary medicines (that are already in the ARTG)
Guidance: online application form for registered complementary medicines
- Getting started: Explains initial setup for access to the TBS portal; and getting to the application form from the TBS 'dashboard';
- Using the form: Explains the 'How to' of the online form, e.g. saving, editing, and validating.
- Completing the form: Explains what information is required in different parts of the form, e.g. applicant details.
Related guidance
All complementary medicine applicants should refer to Australian Regulatory Guidelines Part D: Registered complementary medicines for information on the evaluation process for registered complementary medicines.
Help
- If you require specific help with your registered complementary medicine application, please contact the Complementary and OTC Medicines Branch (COMB).
- For further information about registering and using the TGA Business Services website go to TGA's Business Services (TBS).
Once your application has been submitted
Invoice and payment
Once you have submitted your application, an invoice will be raised comprised of:
- an application fee (non-refundable)
- a pre-determined base evaluation fee (refer to Summary of fees and charges).
For options on how to make your payment, refer to Payment options.
Note
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 TBS application (or include your request in your covering letter).
If successful, the base evaluation fee will be adjusted and a refund may be provided.