What do I require to have a listed medicine in the ARTG?
This tool helps sponsors of listed medicines (AUST L) understand what is required to have their listed medicine in the Australian Register of Therapeutic Goods (ARTG). To supply your medicine in Australia, you need to have it entered in the ARTG by the TGA and be assigned a unique AUST L number.
This guidance is not intended for sponsors of assessed listed medicines (AUST L(A)) or registered complementary medicines (AUST R). For more information about these medicines, see the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).
Some sunscreens are regulated as listed medicines. This tool helps sponsors of listed sunscreens understand their general regulatory requirements. For specific requirements relating to sunscreens please see the Australian Regulatory Guidelines for Sunscreens (ARGS).
New to regulation? The SME Assist section of our website is dedicated to those who are new or unfamiliar with how therapeutic goods are regulated in Australia.
I have further questions about the advertising requirements
All therapeutic goods must comply with the requirements of the Therapeutic Goods Advertising Code.
See the Advertising of complementary medicines webpage for further information on the advertising requirements for listed medicines.
Please contact the TGA for more information about advertising.
Post-market compliance reviews
Because listed medicines are not evaluated by the TGA before being entered on the ARTG and being supplied, we review a proportion of listed medicines post-market for their compliance with the regulatory requirements.
We review listed medicines post-market by conducting:
Random reviews - a proportion of newly listed medicines are randomly selected by computer for review
Targeted reviews - listed medicines identified with potential non-compliance issues are deliberately selected for review
See Listed medicine compliance reviews for more information.
Have you reviewed and understood the information about post-market compliance reviews?
I have further questions about compliance reviews
If you have further questions, please consult the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) and Listed medicine compliance reviews for more information.
Please contact the TGA for more information.
Entering your product on the ARTG
If your goods meet the requirements for listed medicines, your next step will be to submit an application to include your product in the ARTG. You can do this through the TGA Business Services (TBS).
To submit an application, you should follow these steps:
Obtain access to TBS and get a client identification number. See Getting started with the TGA for more information.
Enter the details of your medicine and fill out the application. You can find more information on this process at: Listing a complementary medicine on the ARTG.
Once you submit an application and you have received an AUST L number, you may import, export and supply the goods. There are fees associated with an application for a listed medicine application as well as ongoing charges to keep your product in the ARTG. These can be found in the schedule of fees and charges under non-prescription medicines.
If you need help with your application, refer to the listed medicines application and submission user guide.
Remember that it is the responsibility of the sponsor to ensure the goods remain compliant with all relevant legislation at all times.
Where to go for more help
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provides information on the regulation of complementary medicines in Australia.
The SME Assist page contains general guidance for small to medium businesses, start-ups and those unfamiliar with regulation of therapeutic goods.
You may wish to seek the services of a regulatory affairs consultant to assist you with submitting an application.
If you require assistance throughout the listing process and afterwards, please contact the TGA.
I need further assistance with the other legislative requirements
If you have referred to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) or the Australian Regulatory Guidelines for Sunscreens (ARGS).
Please contact the TGA for more information.
This material is provided by the TGA (a part of the Department of Health) solely to provide a general overview of the TGA regulatory scheme, and particularly to assist small to medium enterprises to better engage with the regulatory scheme. It should not be taken as a detailed description of the scheme or as specific advice on the application of the therapeutic goods legislation in particular cases, nor as a statement of policy.
If you would like further information you should contact the TGA (the TGA website also contains more detailed information on all aspects of the regulatory scheme), or if you need advice on the application of the therapeutic goods legislation in particular cases, you should make your own enquiries to obtain that specific advice.
The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials.
These materials are based on the scheme as at 5 July 2019.
Do you accept the above terms?
Advertisements for therapeutic goods are subject to a number of laws and regulations including the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code (no.2) 2018.
‘Advertise’ in relation to therapeutic goods includes:
Any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
is on the label of the goods; or
is on the package in which the goods are contained; or
is on any material included with the package in which the goods are contained
Any promotional material or activity is considered advertising, not just the label and packaging. Be aware that the following can also be considered:
websites, blogs and other content on the internet
TV, radio, cinema
billboards, public transport
leaflets, flyers, brochures, catalogues and letterbox drops
In general, advertising must promote the quality and safe use of the product. Advertising must not be socially irresponsible, or mislead or deceive the consumer. Also, the sponsor must not advertise the subject goods for an indication other than those included in the ARTG.
You can find more information on advertising requirements on the Advertising Hub.
Have you reviewed the advertising requirements?
I need assistance with the labelling requirements
As labels for listed medicines are not evaluated at the time of listing, it is important that the sponsor ensures that the labels comply with the labelling requirements. You will need to refer to information on labelling & packaging.
You can find more information in Medicines labels: Guidance on TGO 91 and TGO 92.
Please contact the TGA for more information about complementary medicines and labelling.
Other legislative requirements
All therapeutic goods must conform to any applicable standards before they can be entered on the ARTG. The standards recognised under the Therapeutic Goods Act 1989 (the Act) are the default standards and the Therapeutic Goods Orders (TGOs).
The default standards applicable to listed medicines include the:
British Pharmacopoeia (BP)
United States Pharmacopoeia-National Formulary (USP)
European Pharmacopoeia (Ph Eur)
Some of the Therapeutic Goods Orders applicable to listed medicines are the:
Therapeutic Goods Order No 100 – Therapeutic Goods (Microbiological Standards for Medicines) Order 2018
Therapeutic Goods Order No 101 - Therapeutic Goods (Standard for Tablets, Capsules and Pills) Order 2019
To help you understand and interpret the TGOs, there are also guidance documents available:
Have you reviewed and understood the other legislative requirements?
I do not have evidence
It is a requirement under section 26A of the Therapeutic Goods Act 1989 (the Act) or a sponsor to hold evidence to support indications for the product at the time of listing on the Australian Register of Therapeutic Goods (ARTG).
The evidence guidelines specify the type of evidence required to support indications made for listed medicines.
Please contact the TGA for more information about evidence to support complementary medicine indications.
There are multiple pieces of legislation that are used to determine what can and cannot be displayed on your label.
Basic and critical information of what needs to be on your label can be found in the current labelling orders:
Therapeutic Goods Order No. 92 – Standards for labels of non-prescription medicines (TGO 92)
Therapeutic Goods Order No. 69 – General requirements for labels of medicines (TGO 69)
Note that TGO 92 will replace TGO 69 on 31 August 2020. You can use either labelling order until this date, but cannot use both at the same time. All labels must comply with TGO 92 by 31 August 2020.
The overall presentation of your label, including any graphics, claims or indications will also need to comply with the Therapeutic Goods Advertising Code.
The permissible ingredients and permitted indications you have selected for use may also have requirements for advisory statements to be included on your label.
You are not required to submit medicine labels for listed medicines at the time of listing. However, we may request labels at any time as part of a compliance review of your product.
Have you reviewed and understood the labelling requirements?
The indications are not in the Permissible Indications Determination
You can submit an application for an indication to be assessed by the TGA for inclusion in the Determination.
More information can be found at Permitted indications for listed medicines guidance – applying for new indications.
The application fees associated with indication applications can be found in the Summary of fees and charges (under non-prescription medicines).
Please contact the TGA for more information about permissible indications for complementary medicines.
Evidence to support the indications and claims
Sponsors must hold evidence to support any indications and claims they make about their product.
You need to have this information at the time you apply to list your medicine in the ARTG and for the whole time it is entered in the ARTG.
are statements that specify the therapeutic use of the goods
must be included in the ARTG entry for the medicine
must be supported by evidence
do not convey a specific therapeutic benefit (for example, ‘25% more’ or ‘new formula’)
do not need to be included in the ARTG; but
must be supported by evidence
Different indications require different types of evidence. See the Evidence Guidelines for further information. You can find the evidence requirements for sunscreens in the ARGS.
You must hold your evidence at all times while your medicine is listed in the ARTG and ensure that it is relevant and up-to-date. We may ask you to provide your evidence as part of a post-market review of your product.
Do you have evidence to support the indications for the product?
The manufacturer does not have a licence/clearance
Unless exempt, it is a requirement that listed complementary medicines be manufactured in accordance with Good Manufacturing Practice (GMP).
If the manufacturer does not have a licence or clearance, please refer to information on Manufacturing medicines.
Please contact the TGA for more information about manufacturing.
Listed medicines may only contain permitted indications from the Permissible Indications Determination.
There are requirements associated with the use of some indications. You can find these in the Permissible Indications Determination. You can also search for indications and their associated requirements using our database of indications which is available on the TGA Business Services website.
Are all of the indications in the Permissible Indications Determination?
The ingredients are not in the Permissible Ingredients Determination
Where a substance is not currently included in the Permissible Ingredients Determination, or does not have the same prescribed use, you can submit an application to the TGA for the substance to be assessed to see whether it is suitable for use as an ingredient in listed medicines.
We will evaluate your application to determine whether the substance is of sufficiently low risk and safe for use in listed medicines.
For further information on how to apply for the evaluation of a substance, refer to Part C of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).
The application and evaluation fees for a new substance application can be found in the Schedule of fees and charges under non-prescription medicines.
Please contact the TGA for more information about permissible ingredients.
Good Manufacturing Practice (GMP)
Listed medicines must be manufactured in accordance with Good Manufacturing Practice (GMP).
You must ensure that your manufacturer has a licence or clearance for the steps of manufacture required for your type of medicine and dosage form.
For listed medicines, the mandatory steps in manufacture are:
Manufacture of dosage form (for example, tablet)
Packaging & labelling
Release for supply
Testing chemical & physical
It is the responsibility of the sponsor to ensure that the ARTG entry for their medicine lists all of the current manufacturers and each step for which they are responsible. If you change a manufacturer, you must update the medicine’s ARTG entry within 10 days.
All Australian manufacturers of listed medicines must have GMP unless exempt from manufacturing requirements.
Where a product is imported, or if any steps in the manufacture (as listed above) occur outside Australia, the Australian sponsor must hold a GMP clearance issued by TGA for the specific site nominated as the manufacturing site in the ARTG.
The Good Manufacturing Practice application decision tree can help you in determining if GMP licencing, certification or clearance is required.
Check with your manufacturer to make sure that they have the appropriate licence or GMP evidence that they require to support a clearance for your medicine. As a sponsor, you are responsible for ensuring your goods are manufactured by licenced and certified manufacturers. See Manufacturing therapeutic goods for more information.
Does the manufacturer of the product have the appropriate licence or GMP evidence to support an application for a clearance?
Listed medicines may only contain certain low risk ingredients permitted for use in listed medicines. The list of ingredients permitted for use in listed medicines is in the Permissible Ingredients Determination. You will need to check that all ingredients in your proposed listed medicine are permitted ingredients.
When searching the Permissible Ingredients Determination, use Australian approved terminology for the ingredient and note that the Permissible Ingredients Determination is separated into alphabetic volumes. You can also search for ingredients using our database of ingredients which is available on the TGA Business Services website.
There are requirements and restrictions associated with the use of some ingredients in listed medicines. You can find these in the Permissible Ingredients Determination. For your product to be eligible for listing, you must also comply with these requirements.
For example, you cannot use an ingredient in an oral preparation if it is specified as ‘topical use only’ in the Permissible Ingredients Determination.
Are all of the ingredients for your proposed listed medicine in the Permissible Ingredients Determination?
I am not the sponsor
You have indicated that you are not a sponsor. This tool is designed for sponsors to understand requirements for entering listed medicines in the ARTG.
Please contact the TGA for more information.
The product is exempt or excluded
Although the product may be exempt, you need to ensure that you comply with all other applicable requirements. For example, a homoeopathic product may be exempt but must still comply with the labelling and advertising requirements. If your product is excluded, it may not be required to be in the ARTG.
Please contact the TGA for more information about requirements.
Exemptions and exclusions
Some therapeutic goods do not need to be included in the ARTG because they are excluded or exempt.
Excluded goods are products that may fall within the definition of a therapeutic good, however the TGA has declared the product is not a therapeutic good. For example:
hair dyes and moisturising anti-dandruff hair care products
products intended for application to the lips that contain sunscreen
Exempt goods are those that do not need to be in the ARTG under certain conditions. For example:
certain homeopathic preparations
medicines that are dispensed or extemporaneously compounded by practitioners
See Therapeutic Goods Act 1989 (the Act) (Section 18) and the Therapeutic Goods Regulations 1990 (the Regulations) (schedule 5 and 5A) for more information on what is considered exempt.
Have you checked if the product is exempt or excluded?
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Determine if you are a sponsor
The sponsor is responsible for ensuring that their medicine is compliant with all relevant legislation.
A sponsor is a person or company who does one or more of the following:
- exports therapeutic goods from Australia
- imports therapeutic goods into Australia
- manufactures therapeutic goods for supply in Australia or elsewhere
- arranges for another party to import, export or manufacture therapeutic goods
The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia.