To legally supply a medicine in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG).
You can submit your application through our TGA Business Services (TBS) portal. You may need to provide evidence of quality, safety and effectiveness, and pay the required fees.
Applications for higher-risk medicines are assessed to ensure they meet all requirements. If approved, your medicine is added to the ARTG.
Lower-risk medicines are included following your certification that all legal requirements are met. Once included in the ARTG, your medicine can be legally supplied in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medicines. You may also have to meet obligations that apply to all products.
Application pathways and processes
Find application routes to market approval.
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PageInformation on prescription medicine application pathways.
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PageOutline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods.
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PageUnderstand how to apply for market authorisation of therapeutic goods in Australia, including key requirements, approval processes, and regulatory considerations.
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PageOverview of the application process for the different types of non-prescription medicines.
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GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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PageInformation for applicants on requesting and preparing for pre-submission meetings for medicines and biologicals.
Fees and charges
Understand fees, exemptions and how to make payments.
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PageThe Annual Charge Exemption (ACE) scheme provides an exemption from annual charges until a product first generates a turnover.
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PageInformation about annual charges for product entries on the Australian Register of Therapeutic Goods (ARTG) and manufacturing licences.
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PageFind links to TGA fees and payments information, including regulatory fees, charges, payment options, and guidance for therapeutic goods applications and services.
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PageThe following forms are for the use of sponsors and manufacturers mainly regarding the payment of fees and charges.
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PageFind important annual charge deadlines for therapeutic goods, including key dates, payment requirements, and reminders to help you stay compliant with TGA obligations.
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PageAccess to information about fees and payments.
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PageAnnual charges for a licence to manufacture a therapeutic good may be reduced by 50% if the wholesale turnover of that good is below a prescribed level.
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PageView a summary of TGA fees and charges, including application fees, annual charges, and cost recovery arrangements for therapeutic goods in Australia.
Dossier preparation
Learn how to prepare and submit your dossier.
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FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended
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User guideThis document will assist applicants completing biowaiver templates for inclusion in an application for a new prescription generic medicine.
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User guideDossier requirements for literature based submissions.
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User guideThis document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information.
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User guideUser guide for sponsors converting their dossier format from paper, CTD or NeeS to eCTD
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User guideUser guide for sponsors who need to withdraw information from their eCTD dossiers and can be used as best practice for NeeS withdrawals
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User guideInformation on how to compile a literature based submission (including mixed applications).
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.
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PageHow to submit data in the Electronic Common Technical Document (eCTD) format.
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PageFind out how to submit data in the NeeS format.
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GuidanceRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.
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User guideInformation on requirements of a systematic literature search
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PageHow to transfer products under a dossier, including steps for new and previous sponsors, sequence numbering, and what you need to provide.
Product changes and variations
Access information to vary products and sponsorship.
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PageGuidance and updated forms for sponsorship changes and notification obligations.
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GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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GuidanceGuidance to change an OTC medicine, listed in the Australian Register of Therapeutic Goods (ARTG), using the Changes Table.
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GuidanceLearn how to change the sponsor of a therapeutic good in Australia, including requirements, process steps, and regulatory obligations for sponsors and manufacturers.
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
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FormsUse this form to request reinstatement of a cancelled entry on the Australian Register of Therapeutic Goods.
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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for prescription medicines.
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User guideHow to withdraw your Australian Register of Therapeutic Goods (ARTG) application, for medical device sponsors (includes importers and exporters).
Product types