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OTC new medicines registration process

27 August 2020

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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:

  1. Apply as part of the OTC medicine application. If you choose this option, make sure to:

or

  1. 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:

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:

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