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OTC new medicines registration process
Step 2 - Checking for new medicine ingredients
Before you prepare your application to register an OTC medicine, you need to check if the medicine contains a new ingredient or has ingredients that require assessment.
Checking for ingredients in our tables
Check whether the ingredients in the medicine are included in our relevant Tables under Public TGA Information on the business services homepage:
For new proprietary ingredients
Submit the completed Notification of a Proprietary Ingredient form to obtain a proprietary ingredient ID number.
You will need the proprietary ingredient ID number to complete your application to register the medicine (Step 7).
For new substances (excipient or active ingredient)
There are two options to apply for approval of a new substance (excipient or active ingredient.) You can either:
- Apply as part of the OTC medicine application. If you choose this option, make sure to:
- Apply before submitting the OTC medicine application. This option is usually only used for new excipients or active ingredients in sunscreens. If you choose this option, make sure to:
Proposing a name for new substances
You will also need to propose a name for the new substance.
To do this:
- select the relevant application forms for proposing names
- submit the relevant form via email to TGA Names.
- make sure that you state that you have submitted the form in the cover letter of your OTC medicine application or new substance application.
Ingredients that require assessment
Ingredients included in the Ingredient Table may not have been approved for your proposed use or at the proposed concentration.
The Ingredient Table includes limited information on the restrictions for use (for example, for topical use only).
The absence of restrictions in the Ingredient Table does not mean that the ingredient has been approved for your proposed use or at the proposed concentration.
If the proposed use or concentration is not typical for your ingredient or you are not sure whether your ingredient has been assessed for your proposed use or at the proposed concentration you can contact OTC Medicines by email.
If your ingredient requires assessment of safety and efficacy data make sure to:
- take this into account when you determine the application level (see Step 3)
- state this in the cover letter of your OTC medicine application.
- provide the required data, in accordance with the Guidelines on OTC applications for new substances.