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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PageOrphan drug designation allows for a waiver of the application and evaluation fees to register drugs that treat rare medical conditions.
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PageThe priority review pathway is a formal mechanism for faster assessment of vital and life-saving prescription medicines.
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PageThe provisional registration pathway expedites early access to promising new medicines. This is for a limited time while you conduct clinical studies to confirm the medicine's benefit.
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PageThe intended purpose of assessed listed medicines pathway is not to assess complementary medicines that only make low level indications (indications that are, or meet the criteria to be included on the permitted indications list).
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PageThe assessed listed medicines pathway is a new listing pathway through which sponsors can apply to list a complementary medicine into the Australian Register of Therapeutic Goods (ARTG).
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FormsThis form must be completed and submitted for all L(A)1 applications in Module 1.5.7 of the application. Completing this form provides the assurances required to accompany a L(A)1 application.
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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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PageLearn about sponsor certification of regulatory requirements for listed and assessed listed medicines
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PageFind information about using reports from Comparable Overseas Bodies for applications for listed, assessed listed and registered complementary medicines.
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PageLinks to information on how the Therapeutic Goods Administration (TGA) uses assessments from comparable overseas regulators (CORs).
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User guideThis is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.
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User guideThis user guide will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries)
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PageA new Data Protection Scheme is now available for assessed listed medicine applications.
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FormsChecklist to assist in a priority review designation application
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FormsThis checklist is to be used by sponsors to apply for priority review determination
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FormsThis checklist is intended to assist applicants to determine if they have provided all the necessary information to allow the TGA to make an informed decision on the determination application.
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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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ServiceOutline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods.
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User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
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PageInformation about including listed complementary medicines on the ARTG
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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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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
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GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
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GuidanceGuidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
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FormsThe Module 1.2.1: Assessed listed medicine general application information form must be completed in conjunction with the Assessed listed medicines application form.
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User guideThe OTC application categorisation framework defines the different OTC medicine application levels and identifies the key application criteria
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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 how applications to register an OTC medicine are categorised into five levels based on risk.
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PageKnow which ingredients we permit in listed and assessed listed medicines and learn about why and when we make changes.
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PageFind out about our clinical evaluation streams and the functions each unit provides.
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PageApproved determinations and designations for prescription medicines
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GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
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User guideStep by step user guide on submitting applications to register a complementary medicine or over the counter (OTC) medicine in the Australian Register of Therapeutic Goods, using the TGA Business services.
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GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
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PageFind out about fees and charges that apply from January 2025.
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GuidanceGuidance for holding acceptable evidence to support indications and claims made about your listed medicine.
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PageWe aim to complete the OTC medicine evaluation process within a specified target time.
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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 the regulatory requirements for assessed listed medicines.
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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 explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceThis guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
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GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
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PageHow to select and use permitted indications for your listed medicine
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GuidanceGuidance on using reports from COBs and submission requirements for evaluation of these applications.
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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PageGuidance on the submission requirements for the prescription medicines COR report-based process.
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PageEvaluation plan estimators to approximate dates of milestones in the prescription medicine registration process.
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User guideInstructions for applicants on how to organise and fill out a pre-submission planning form (PPF).
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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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FormsUse these forms to request a meeting and to record agenda items and outcomes.
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PageInformation for applicants on how to request and prepare for pre-submission meetings.
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PageInformation about the pre-submission planning form (PPF) for prescription medicine applications.
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PagePre-submission planning is the first phase of the prescription medicines registration process.
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PageInformation for sponsors on demonstrating stability of medicines under Australian conditions.
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LegislationThis Determination specifies what information must accompany applications to list complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
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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GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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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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GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
Dossier preparation
Learn how to prepare and submit your dossier.
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
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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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GuidanceThis guidance explains the administrative and prescribing (dossier) information you need to support the registration or variation of a prescription 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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FormsPlease include this form in CTD Module 1.5 of your application dossier.
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GuidanceGuidance on dossier information required for registered complementary medicine applications, 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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PageDossier requirements for non-prescription medicines
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FormsComplete this form when submitting a new DMF to TGA, or when updating an existing DMF already held by the TGA.
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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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FormsA list of TGA forms for prescription medicine sponsors.
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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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FormsThe Module 1.2.1: Assessed listed medicine general application information form must be completed in conjunction with the Assessed listed medicines application form.
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User guideThe OTC Dossier Documents Matrix (the 'matrix') provides a summary of which documents are required for each application level (N1, N2, N3, N4, N5, C1, C2, C3 or C4)
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User guideThe cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application
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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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FormsSubmission dossier checklist for prescription medicines
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FormsUse this form when submitting an updated RMP after regulatory approval
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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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PageFind out how to submit your prescription medicine application and dossier.
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GuidanceGuidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer.
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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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PageData the TGA evaluates before a prescription medicine can be registered in the Australian Register of Therapeutic Goods (ARTG).
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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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LegislationThis Specification provides what information must accompany an application to register complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
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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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FormsSponsors can use this form to apply for an additional trade name for a registered prescription medicine, under section 23 of the Therapeutic Goods Act 1989.
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FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.
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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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User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
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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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PageFurther information on next steps in implementing a notifications process for registered medicines
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PageUpdates to FAQs re the prescription medicines variations e-form
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User guideThis user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription OTC medicine.
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FormsThe Registered medicine variation form (complementary medicines) should only be used when you wish to vary the particulars of complementary medicines which are already registered in the ARTG.
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GuidanceGuidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
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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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GuidanceGuidance about the types of notifications and variations for biological medicines.
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GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
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PageLinks to information on variations to prescription medicines and biologicals.
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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for your non-prescription medicine
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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