The TGA Business services (TBS) portal provides an electronic facility for the listing and registration of medicines on the Australian Register of Therapeutic Goods (ARTG).
To apply for a TGA client ID and access to the TBS portal, please see TGA Business Services: getting started with the TGA. Information regarding the various 'roles' within TBS can be found at TGA Business Services - how to use the site under Roles: what each user can do.
The TBS portal can be accessed through your web browser using either - Internet Explorer, Google Chrome, Firefox or Safari.
Registered complementary and over-the-counter medicines
The Common Technical Document (CTD) sets out the format for an application when applying to register a medicine in the Australian Register of Therapeutic Goods (ARTG).
The CTD specifies the organisation of the information across 5 modules so they are grouped logically and can be easily located:
- Module 1: Administrative information and prescribing information for Australia
- Module 2: Summaries of quality, safety and clinical data
- Module 3: Quality
- Module 4: Non-clinical data (safety)
- Module 5: Clinical data (efficacy)
The actual content of the dossier for a registered non-prescription medicine application will vary according to the application category.
Assessed listed medicines
The application dossier for assessed listed medicines is based on a simplified version of the CTD structure. This structure allows evaluators to quickly and efficiently locate specific information.
You are encouraged to request a pre-submission meeting with the TGA to ensure you are aware of the legislative requirements for the assessed listed pathway and the data required for an application to be accepted for assessment. If it is determined at the meeting that the proposed data dossier is likely to be critically deficient, sponsors have the opportunity to address these deficiencies prior to submitting their application.
Listed medicines
Listed medicines are considered to pose a low risk to consumers than registered medicines based on their ingredients and/or the therapeutic indications.
Listed medicines can be sold without undergoing a full pre-market assessment of safety, quality and efficacy by the TGA because they satisfy certain criteria. Sponsors certify at the time of listing their medicine on the ARTG that they have met legislative requirements and hold evidence to support their medicine.
An evidence package should contain a critical appraisal of your evidence and demonstrate how it supports the listed medicine’s efficacy.
- Evidence needed for non-prescription medicine indicationsPageAppropriate evidence is needed to support any indications made in relation to your medicine
- Manufacturing evidence for non-prescription medicinesPageManufacturing evidence for non-prescription medicines
- Safety and Quality of non-prescription medicinesPageAssuring the safety and quality of non-prescription medicines
Additional resources
- Listed medicines trainingGuidanceLearning modules for sponsors of listed medicines as a supplement to Evidence Guidelines.
More information
Listed and assessed listed medicines
- Guidance for completing the application form for an assessed listed medicine
-
Listed and assessed listed medicines: Application and submission user guide
- Mandatory requirements for an assessed listed medicine application to pass preliminary assessment
- CTD Module 1: Administrative information for assessed listed medicines
- Module 1.2.1: Assessed listed medicine general application information form
- CTD Module 1.5 - Assessed listed medicines - Restricted information certification form
- Assurances to accompany a L(A)1 application
- Australian regulatory guidelines for sunscreens (ARGS)
Registered non-prescription medicines
- Application for a new registered complementary medicine - grouped medicine
- OTC application placement flowchart
- OTC application placement question and answer tool
- Preparing an OTC application cover letter
- OTC new medicines registration process
- Registered complementary and OTC medicines application and submissions
- Mandatory requirements for an effective registered complementary medicine application
- OTC medicines advisory committee process