To be a listed medicine on the Australian Register of Therapeutic Goods (ARTG) a product:
- can only contain certain low risk ingredients in acceptable amounts that are permitted for use in listed medicines by the TGA
- must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP)
- can only make indications (for therapeutic use) for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions.
At the time of submitting a listed medicine application to the TGA, the sponsor must certify that the goods in the application meet all of the legislative requirements of section 26A (Part 3-2, Division 2) of the Therapeutic Goods Act 1989 (the Act).
Medicines listed on the ARTG are assigned a unique AUST L number, which must be displayed on the medicine label.
To better understand your responsibilities when entering a listed medicine on the ARTG, please see our tool What is required when entering a listed medicine on the ARTG.
Evidence for indications for listed medicines
The therapeutic indications on listed medicines are not evaluated by the TGA at the time a medicine is listed on the ARTG. However, the Act requires that, at the time of listing, sponsors certify that they hold the evidence to support indications and claims made for their medicine and that this information be made available to the TGA upon request.
The Evidence guidelines assist sponsors in determining the level of evidence required to support indications made for complementary medicines.
Listed medicines for export
Medicines intended solely for the purpose of export are required to be listed (not registered) on the ARTG before export is commenced. Refer to Exporting medicines for more information.
How to list a medicine on the ARTG
Listed medicines are included on the ARTG via a streamlined electronic listing facility which is part of the TGA's eBusiness services (eBS) framework. The process for listing products allows for early market access for complementary medicines.
Access to the electronic listing facility is via a secure login on the eBS homepage and requires a user name and password. The Electronic listing facility (ELF) user guide is available on the TGA website. In order to get access to eBS, applicants must first submit a Client Details form and obtain a 'client identification number'. Having obtained a client identification number, an eBS Access Request Form can be submitted. The TGA will establish access for the applicant to become the 'E-Business Administrator' for their company and then applications for user accounts for themselves and other personnel in their company can be made.
For further information about obtaining a client identification number or gaining access to eBS, contact the TGA by phone 1800 010 624 or email ebs@tga.gov.au.
An application (to either list a new complementary medicine or update information on an existing listed medicine) must pass validation in the electronic system before a sponsor can submit the application to the TGA. The applicant must certify, upon submission of their application to the TGA, that the goods that are the subject of the application meet all the requirements of listing.
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provides greater detail on the listing process for complementary medicines.
If you are a sponsor who has no previous experience with listing or registering a medicine in Australia, you may wish to seek the services of an Australian regulatory affairs consultant.
Amendment of product details of a listed medicine included on the ARTG
On occasion, sponsors may need to update certain product details included in the ARTG for their listed medicine.
Where the intended change does not create a 'separate and distinct' good - Section 16 (1A) of the Act outlines the criteria which make listed medicines (other than those listed for export only) 'separate and distinct' goods - there are provisions in the legislation for certain details to be amended on a medicine's ARTG entry, upon request by the sponsor, and maintain the same AUST L number. Minor changes to listed medicines on the ARTG (other than those listed for export only) are made via the eBS system. For further information, including the types of changes that incur a fee, refer to the document: Guidance on product changes in ELF 3.
If the intended change to the listed medicine creates a good that is considered to be separate and distinct from the existing good, sponsors are required to submit a new application to list the goods and a new AUST L number will be issued (unless the medicine is eligible for 'grouping' under the existing AUST L number - see Therapeutic Goods (Groups) Orders.
Listed complementary medicine compliance reviews
On average, there are approximately 1800 new listed complementary medicines entered on the ARTG each year. As the TGA cannot review all listed complementary medicines, a risk management approach is used to set priorities for Listed complementary medicine compliance reviews. Reviews can be:
- Random reviews: A proportion of newly listed medicines randomly selected by computer, based on a mathematical model, for compliance review.
- Targeted reviews: If a listed complementary medicine is identified with potential non-compliance issues it may be selected for a compliance review. Issues of potential non-compliance may be brought to the TGA's attention by a number of sources, including the public, media, health care professionals or other external sources, information from other regulatory agencies, screening of the ARTG for recently listed medicines and information from previous compliance reviews.