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An overview of over-the-counter medicines

Start here to get an overview of how your product is regulated and helpful information to support your journey. 

If you're planning to bring an over-the-counter (OTC) medicine to market in Australia, this is your starting point.

You need to understand how we regulate these products and your obligations at each stage of the medicine's lifecycle. This includes choosing the right pathway, preparing evidence, and meeting quality and safety requirements for your medicine.

Being well prepared helps ensure your product meets Australian requirements and avoids delays in the approval process.

Start by learning your responsibilities and planning each stage of your product’s lifecycle. 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to over-the-counter medicines. You may also have to meet obligations that apply to all medicines and all products. 

General information

Learn about how products are regulated.

Ingredients and scheduling

Get information about ingredient approvals and scheduling requirements.

  • Public notices about scheduling

    Page
    Links to public notices on invitations for and public comment on scheduling proposals, scheduling decisions, applications and other consultations and reviews.

  • Scheduling of medicines & poisons

    Page
    Links to and information on scheduling and the Poisons Standard including public notices, state and territory information, the scheduling advisory committees and proposed committee meeting dates and decision timeframes.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

Standards and requirements

Understand product obligations for safety, quality and efficacy.

Product types