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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PageThe ARGLM will help you navigate the regulatory requirements for listed and assessed listed medicines in Australia.
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PageThe ARGPM will help you navigate the regulatory requirements for prescription medicines in Australia.
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PageThe ARGRCM will help you navigate the regulatory requirements for registered complementary medicines in Australia.
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GuidanceFind out whether your application for an umbrella-branded medicine requires a higher level of assessment.
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PageRegistered over-the-counter medicine application levels.
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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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GuidanceHow to confirm that your OTC application is an N1 application and how to compile the information and assurances for N1 applications.
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PageUse this tool to categorise an application to register a 'new' OTC medicine into the right application level.
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PageFind the monographs available for over-the-counter (OTC) new medicine N2 applications.
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PageOverview of the process to follow if you want to supply therapeutic goods in Australia
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PageFind out about our clinical evaluation streams and the functions each unit provides.
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PageOverview of the application process for the different types of non-prescription medicines.
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GuidanceTo use the N2 application pathway using OTC medicine monographs, you must ensure that your application meets the requirements for N2 applications.
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GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
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GuidanceThis guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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PageEvaluation plan estimators to approximate dates of milestones in the prescription medicine registration process.
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GuidanceGuidance about information required for an assessed listed medicine application to pass preliminary assessment and proceed to evaluation.
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GuidanceGuidance on submitting an effective application to register an over-the-counter (OTC) medicine.
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PageUse this tool to categorise an application to register a 'new' OTC medicine into the right application level.
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PageInformation for applicants on how to request and prepare for pre-submission meetings.
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PageInformation for sponsors on demonstrating stability of medicines under Australian conditions.
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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PageThe following forms are for the use of sponsors and manufacturers mainly regarding the payment of fees and charges.
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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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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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GuidanceGuidance about administrative information to support over-the-counter (OTC) medicine applications in Australia.
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PageHow to compile a baseline sequence when transitioning your dossier from non-eCTD electronic submission (NeeS) to eCTD format.
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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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GuidanceGuidance about the administrative information to support assessed listed medicine applications.
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GuidanceGuidance for applicants on information required for Module 1 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format.
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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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PageInformation for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines.
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PageExplore frequently asked questions raised by industry in relation to permitted indications.
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PageLearn the main terms and concepts for sending data to us in electronic eCTD format.
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User guideInformation on how to compile a literature based submission (including mixed applications).
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GuidanceGuidance on submitting an effective prescription medicines application.
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GuidanceGuidance on information required for an effective application to register a complementary medicine and proceed to evaluation.
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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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PageTechnical rules for ensuring your NeeS sequence is valid.
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PageThis page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA
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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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PageHow to submit applications, reports and documentation in the electronic common technical document (eCTD) and non-eCTD electronic submission (NeeS) formats.
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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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PageModule 1 is the section that contains administrative information about your electronic Common Technical Document (eCTD) submission specific to Australia.
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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.
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PageHow to withdraw information from your eCTD dossier.
Product changes and variations
Access information to vary products and sponsorship.
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ChecklistsThis checklist assists sponsors to prepare a change application at the C1 level for a registered OTC medicine.
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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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GuidanceGuidance for what to do if the sponsor of a therapeutic good changes.
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GuidanceFind out whether your application for an umbrella-branded medicine requires a higher level of assessment.
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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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PageHow to withdraw information from your eCTD dossier.
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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