TGA evaluation of non-prescription medicines
Submit an application for a non-prescription medicine.
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.
Listed and assessed listed medicines
AUST L, listed medicines are considered to have a lower risk as they may only use low-risk ingredients and low-level indications that must be selected from the pre-approved lists. Listed medicines are not individually evaluated by the TGA before they are released onto the market; instead, they are automatically included in the ARTG following completion of an application and certification by the sponsor that their product meets all applicable legislative requirements in relation to safety, quality and efficacy. Listed medicines have an AUST L number on their medicine label.
AUST L(A), assessed listed medicines may only use low-risk ingredients permitted for use in listed medicines. However, they must have at least one intermediate indication (i.e. indications that are above those available for AUST L listed medicines),and may also include lower-level indications. Assessed listed medicines are entered in the ARTG following self-certification by the applicant of the safety and quality of the product and TGA pre-market assessment of the efficacy evidence supporting the proposed indications. Assessed listed medicines have an AUST L(A) number on their medicine label.
Conditions of listing
Therapeutic Goods (Listed Medicines - Conditions of Listing) Determination 2022- external site
Sets out the standard conditions that will automatically apply to the listing of certain medicines that are listed in the Australian Register of Therapeutic Goods (ARTG) under section 26A or 26AE of the Therapeutic Goods Act 1989.
Registered non-prescription medicines
AUST R registered complementary medicines and over the counter medicines (OTC) are considered to be relatively higher risk than listed medicines, based on the ingredients they contain or the indications made for the medicine. All registered medicines are fully assessed by the TGA for quality, safety and efficacy prior to being available in the Australian market. Registered medicines have an AUST R number on the medicine’s label.
Registered non-prescription medicine evaluations have time frames. See Target evaluation times for OTC medicines
Fees and charges
The TGA has a variety of fees and charges for non-prescription medicines:
- an initial application fee
- evaluation fees
- an annual charge to maintain the inclusion of their product in the ARTG.
The fees payable vary depending on the type of application. See Schedule of fees and charges to applications submitted to the TGA.