Understanding the legislative framework for listed medicines

Listed medicines are considered to have a lower risk for consumers than registered medicines because of the low risk ingredients and/or the low-level indications (intended uses) they are allowed to use. Listed medicines included in the Australian Register of Therapeutic Goods (ARTG) can be sold to the general public without undergoing a TGA full pre-market assessment of safety, quality and efficacy because they satisfy certain ‘low risk’ criteria. This allows for rapid market access for listed medicines compared with registered medicines.

There are two different pathways for including listed medicines in the ARTG for supply in the Australian market:

• Listed medicines: these have an ARTG identification starting with AUST L. 

  There is no TGA pre-market assessment of medicines under this pathway. The medicine is included in the ARTG following self-certification by a sponsor that your medicine meets all legislative requirements.

• Assessed listed medicines: these have an ARTG identification starting with AUST L(A). There is a TGA pre-market assessment of the medicine’s efficacy under this pathway.

Assessed listed medicines differ from listed medicines principally in that they are allowed to use intermediate level indications. Like other listed medicines, assessed listed medicines are entered in the ARTG following self-certification by the sponsor of the safety and quality of the product. However, unlike other listed medicines, assessed listed medicines undergo a TGA pre-market assessment of the efficacy evidence supporting the product’s indications.

In brief, you can access the pathways to list a medicine in the ARTG if:

• your medicine is eligible for listing; and
• your medicine complies with the requirements of 
  • section 26A of the Therapeutic Goods Act 1989 (the Act) for listed medicines; and
  • sections 26AB and 26AE of the Act for assessed listed medicines. 

Sections 26A and 26AB of the Act contain the certification requirements for each pathway (see ‘Listed medicine sponsor certifications under the Act’ in this guidance). 

The requirements for the pre-market assessment of efficacy for assessed listed medicines are in section 26AE of the Act.

Medicines eligible for inclusion in the ARTG as listed medicines

AUST L: A medicine is eligible for inclusion in the ARTG as a listed medicine under section 26A of the Act if:

• the medicine only contains ingredients, and complies with the requirements, specified in the Therapeutic Goods (Permissible Ingredients) Determination (the Permissible Ingredients Determination)

• the medicine only has indications that are covered by the Therapeutic Goods (Permissible Indications) Determination (the Permissible Indications Determination) and complies with any requirements specified therein—Refer to Permitted Indications for listed medicines

• the medicine consists entirely of ingredients that do not need to be sterile, such as those not typically found in eye drops or injections; and

• the medicine does not contain a substance included in a Schedule to the Poisons Standard (SUSMP).

AUST L(A): A medicine is eligible for inclusion in the ARTG as an assessed listed medicine under section 26AE of the Act if:

• the medicine only contains ingredients, and complies with the requirements, specified in the Permissible Ingredients Determination

• the indications proposed for the medicine:

  • only refer to:

    • preventing, curing, or alleviating a non-serious form of a disease, ailment, defect, or injury, or

    • alleviating a serious form of a disease, ailment, defect or injury (as identified in the Therapeutic Goods Advertising Code), but not preventing or curing such a disease 

  • do not refer to a prohibited representation (within the meaning of Part 5‑1 of the Act)

• the medicine consists entirely of ingredients that do not need to be sterile, such as those not typically found in eye drops of injections; and

• the medicine does not contain a substance included in a Schedule to the Poisons Standard (SUSMP).

AUST L(A) medicines (as well as AUST R registered complementary medicines - see Submitting an application for a registered complementary medicines) are eligible to include a ‘TGA assessed’ claim on their medicine label and other advertising material indicating that the TGA has assessed the evidence the sponsor holds for the efficacy of your medicine’s indications. The use of the TGA assessed claim is optional—refer to Using the ‘TGA assessed’ claim on medicine labels.

Refer to the Listed and assessed listed medicines: Application and submission user guide for more information on the process of listing a listed medicine or an assessed listed medicine in the ARTG.

Sponsor responsibilities for listing a medicine in the ARTG

Requirements and responsibilities for listing medicines in the ARTG

A medicine is listed in the ARTG on the basis of:

• information provided by the sponsor; and
• certifications by the sponsor made at the time of application that the goods (that are the subject of the application) meet the relevant legislative requirements - see ‘Listed medicine sponsor certifications under the Act’ in this guidance.

Important:

Sponsors must ensure they have all the relevant information and supporting evidence available before submitting an application to list a medicine.

Sponsors should not submit an application for listing on the basis that information, evidence or manufacturing arrangements necessary to support sponsor certifications will be obtained or finalised after listing.

Before submitting an application, sponsors should be satisfied that critical elements of the medicine, such as its formulation, manufacturing arrangements, specifications, shelf life and any evidence required to support certifications, have been appropriately established and documented.

Ensuring these matters have been established before listing supports the accuracy of sponsor certifications and the integrity of the listed medicines framework.

Important:

An incorrect sponsor certification could result in your product listing being cancelled from the ARTG [e.g. under section 30(2)(ba) or (bab) of the Act or other cancellation grounds]. Other Compliance actions and outcomes, such as the imposition of fines or product recall, could also be taken.

Once a medicine is accepted for inclusion in the ARTG, you must comply with all the conditions of listing applicable to the medicine - see ‘Conditions of listing’ later in this guidance.

Listed medicine sponsor certifications under the Act

When listing a medicine in the ARTG, sponsors make a number of certifications under the Act.

For AUST L listed medicines the sponsor certifications are made against:

• section 26A(2)(a)–(k) of the Act; and
• if applicable, section 26A(2A) of the Act.

For AUST L(A) assessed listed medicines the sponsor certifications are made against:

• section 26AB(2)(a)–(q) of the Act; and
• if applicable, section 26AB(3) of the Act.

Details on the required sponsor certifications are provided below. 

The medicine is eligible for listing

Sponsors of all listed medicines are required to certify that your medicine is eligible for listing [against sections 26A(2)(a) or 26AB(2)(a) of the Act]. See ‘Medicines eligible for inclusion in the ARTG as listed medicines’ above in this guidance. 

The medicine is safe for the purposes for which it is to be used

Sponsors of all listed medicines are required to certify [against sections 26A(2)(b) or 26AB(2)(b) of the Act] that your medicine is safe for the purposes for which it is to be used. Certain regulatory restrictions and/or controls may be imposed to ensure that the use of a listed medicine is low risk, such as label advisory statements, restrictions on dosage, and restrictions on route of administration. 

Sponsors must ensure that they are aware of every condition or restriction affecting the use of ingredients (including proprietary ingredients) in your product so that the product fully complies with all regulatory requirements applicable in Australia.

The presentation of the medicine is not unacceptable

Sponsors of all listed medicines are required to certify [against sections 26A(2)(c) or 26AB(2)(c) of the Act] that the presentation of your medicine is not unacceptable. 

In brief, ‘presentation’ is defined in section 3(1) of the Act and includes matters relating to the name of the goods, the labelling and packaging, and any advertising or other informational material associated with the goods. The presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content, proper use, or identification of the goods: section 3(5) of the Act. For more information refer to: Understanding labelling and presentation requirements for listed medicines.

The medicine only contains permissible ingredients and complies with ingredient requirements

Sponsors of all listed medicines are required to certify [against sections 26A(2)(ca) or 26AB(2)(d) of the Act] that your medicine only contains low risk ingredients permissible for use in listed medicines, as included in the Permissible Ingredients Determination.

Sponsors also certify [against sections 26A(2)(cb) or 26AB(2)(e) of the Act] that your medicine complies with any specific requirements relating to the use of ingredients included in the Permissible Ingredients Determination, for example: label advisory statements.

The majority of ingredients that can be included in listed medicines are those that were included in therapeutic goods supplied in Australia before the Act came into operation in 1991. Since then, all new active and excipient ingredients have undergone a safety assessment by the TGA. If you wish to include an active or excipient ingredient in your medicine that is not currently approved for use in listed medicines, the substance must be evaluated by the TGA before such use is permitted - refer to Understanding the applications requirements for a new substance in listed medicines for information on this process.

The medicine conforms to all applicable standards 

Sponsors of all listed medicines certify [against subsections 26A(2)(d) and 26AB(2)(f) of the Act] that your listed medicine conforms to applicable standards before it is entered in the ARTG.

Important:

It is an offence under the Act to import, supply or export therapeutic goods that do not comply with a standard applicable to the goods, unless you have received prior consent in writing (see section 14 and 14A of the Act). Refer to Consent to import, supply or export therapeutic goods that do not comply with standards – information for industry

The medicine complies with all advertising requirements

Sponsors of all listed medicines certify [against sections 26A(2)(da) and 26AB(2)(g) of the Act] that your medicine complies with any requirement applicable under: 

• the Therapeutic Goods Advertising Code
• part 5-1 (Advertising and generic information) of the Act; and
• the Therapeutic Goods Regulations 1990 (the Regulations).

For guidance on advertising medicines, refer to:

• Applying the Advertising Code
• Restricted and prohibited representations in advertising 

Important:

Under section 28(5)(ab) of the Act, it is an automatic condition of listing for all listed medicines that a sponsor will not, by any means, advertise the goods for an indication other than those accepted in relation to the inclusion of the goods in the ARTG.

Refer to Permitted indications for listed medicines for further information about using permitted indications.

The medicine complies with manufacturing requirements

Sponsors of all listed medicines are required to certify that your medicine complies with applicable manufacturing requirements in sections 26A and 26AB (which are discussed later in this guidance). Unless exempt, (see ‘Products exempt from certain manufacturing requirements’ in Understanding listed and registered complementary medicine regulation) all listed medicines included in the ARTG must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP). 

Australia has codes of GMP and quality system requirements for the manufacture of therapeutic goods, including complementary medicines. For more information—refer to PIC/S Guide to GMP for medicinal products and Performing product quality reviews (PQRs) for listed and complementary medicines.

All the manufacturers of the listed medicine are nominated

Sponsors of all listed medicines certify [against sections 26A(2)(h) and 26AB(2)(o) of the Act] that all the manufacturers of the medicine are nominated as manufacturers in the sponsor’s application. The electronic listing system supports this process by providing for the manufacturers undertaking principal manufacturing steps in the manufacture of the medicine to be entered in the system. Use of a manufacturer of the medicine for such steps who is not nominated in the application will result in an incorrect certification and can result in quality, safety and efficacy concerns for the medicine that is manufactured.

Written agreements between sponsor and manufacturers are in place

Sponsors of listed medicines also certify [against sections 26A(2)(i) or 26AB(2)(p) of the Act] that you have written agreements in place with all the manufacturers of your medicine to ensure that the manufacture of the medicine allows you to meet all the legal obligations for which you are liable.

Australian manufacturer(s) used hold a GMP license

Where the medicine is manufactured in Australia, sponsors of listed medicines certify [against sections 26A(2)(e) or 26AB(2)(h) of the Act] that each step in the manufacture of the medicine (where manufactured in Australia) is carried out by a licensed manufacturer - who is the holder of a manufacturing licence to carry out that step (unless the therapeutic good is exempt from this requirement)—refer to Manufacture of therapeutic goods. 

Australian manufacturers who are involved in the manufacture of active ingredients, mixtures containing active ingredients and any other step taken to bring therapeutic goods to their final state (e.g. intermediate manufacturing steps, testing, packaging/labelling and release for supply) are required to have a licence under Part 3-3 of the Act, unless specifically exempted.

Important:

It is an offence, carrying heavy penalties, under Part 3-3 of the Act, to manufacture therapeutic goods in Australia for human use without a licence unless the manufacturer or goods are exempt. There are also civil penalty provisions. The manufacturer’s licence carries details of the types of manufacture permitted under the licence.

There is an automatic condition of listing, for AUST L and AUST L(A) medicines, that each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a manufacturing licence unless the manufacturer or the goods are exempt from these requirements (section 28(5B) of the Act).

Overseas manufacturer(s) hold a GMP clearance or certification

Where a product is imported, or if any steps in the manufacture of a listed medicine take place outside Australia, the international manufacturer must hold a TGA GMP clearance or certification—refer to Overseas manufacturers.

Where a product is imported, each nominated international manufacturer must demonstrate an acceptable standard of GMP as would be required of an Australian manufacturer. Pre-clearance of international manufacturers is mandatory for listed medicines—refer to Overseas manufacturers.

Important:

There is an automatic condition of listing, for AUST L and AUST L(A) medicines, that each step in the manufacture of the medicine that is carried out outside Australia is the subject of certification by the Secretary (of the Department of Health, Disability and Ageing) that the manufacturing and quality control procedures are acceptable (unless the medicine is exempt from the operation of Part 3-3 of the Act).

While each step in the manufacture of the medicine is required to be manufactured in accordance with the principles of GMP, not all steps are required to be entered in the medicine’s ARTG entry. Refer to Listed and assessed listed medicines: Application and submission user guide.

The medicine complies with quality and safety criteria

The sponsor of the listed medicine is responsible for the quality (and safety) of your listed medicine. You must hold information or evidence to demonstrate that your medicine:

• complies with all legislative requirements; and
• meets all specifications for the shelf life of the medicine, the recommended storage conditions, and the expiry date stated on the medicine label (more information about a medicine’s specifications is provided later in this guidance).

Sponsors are required to certify [against sections 26A(2)(f) or 26AB(2)(i)] of the Act] that your medicine complies with any additional prescribed quality or safety criteria. 

Note: a delegate of the Secretary (of the Department of Health, Disability and Ageing) can require information or documents about the quality of a listed medicine under section 31(2)(ca) of the Act; and can cancel a medicine’s listing under section 30(2)(a) if the quality of the medicine is unacceptable. For more information, refer to guidance on Understanding quality requirements for listed medicines.

The medicine’s specifications comply with requirements 

The sponsor of a listed medicine certifies [against sections 26A(2)(fa) and 26A(2)(fc) or 26AB(2)(j) and 26AB(2)(l)) of the Act] that:

• your medicine’s specifications comply with any requirements that are prescribed by the Regulations applicable to your medicine: and
• you hold information or evidence showing your medicine’s specifications will be maintained under the conditions set out on your medicine’s label until the medicine’s expiry date.

The medicine label complies with requirements

The sponsor of a listed medicine certifies [against sections 26A(2)(fb) or 26AB(2)(k) of the Act] that your medicine label does not include any claim that is inconsistent with the claims in the application (e.g. as made for the proposed ARTG entry) and, complies with any additional requirements prescribed by the Regulations applicable to your medicine. 

Sponsors of AUST L medicines are also required to certify [against section 26A(2)(fba) of the Act] that proposed indications on your medicine’s label are permitted indications under the Permissible Indications Determination.

For more information on claims and indications see Permitted indications for listed medicines.

Medicines (including labels) must comply with applicable standards and advertising requirements. Refer to Understanding labelling and presentation requirements for listed medicines.

The medicine only contains permissible indications and all requirements relating to those indications are met

Sponsors of AUST L medicines are required to certify [against section 26A(2)(fd) of the Act] that each proposed indication for your medicine is covered by the Permissible Indications Determination. You also certify [against section 26A(2)(fe) of the Act] that all requirements relating to those indications in the Permissible Indications Determination are met.

The medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901

Sponsors of all listed medicines are required to certify [against sections 26A(2)(g) or 26AB(2)(n) of the Act] that your medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901 (and the Customs (Prohibited Imports) Regulations 1956).

Evidence is held for all indications and claims

At the time of the application for listing, sponsors of AUST L medicines certify [against section 26A(2)(ja) of the Act] that you hold evidence to support any permitted indication for your medicine (and comply with the applicable legislative requirements, if any, for that evidence). 

You also certify [against section 26A(2)(j) of the Act] that you hold evidence to support any claims (that are not indications) made for your medicine (and comply with the applicable legislative requirements, if any, for that evidence). 

Refer to Supporting claims and indications for listed medicines to assist you to determine the appropriate evidence to support therapeutic indications and claims made in relation to your AUST L medicine.

For AUST L(A) medicines, sponsors certify [against section 26AB(2)(m) of the Act] that you have sufficient information to substantiate each claim and each indication made for your medicine. Sponsors of an AUST L(A) medicine must provide your evidence to the TGA for pre-market assessment.

TGA assessment of efficacy data for an AUST L(A) medicine is based on the finished product (rather than active ingredients in isolation) and includes a detailed evaluation of evidence to support all intermediate and lower level indications – refer to Understanding the application requirements for an assessed listed medicine.

Important:

For AUST L medicines there are automatic conditions of listing, under sections 28(6) and (7) of the Act, sponsors must hold evidence to support any claims or indications made for your medicine Evidence for claims and indications must be held at the time when the claim or indications was made and be retained at all times while your medicine remains listed in the ARTG. You must also provide the evidence for your medicine’s claims or indications to the TGA, if requested, at any time while your medicine remains in the ARTG.

For AUST L(A) medicines, there is an automatic condition of listing that sponsors must hold evidence to support indications at all times while your medicine remains in the ARTG, and that you will provide this evidence to the TGA if requested, at any time while your medicine remains in the ARTG (section 28(8) of the Act).

After listing, the medicine may be subject to a compliance review of the evidence you hold, as part of the TGA’s post-market monitoring activities, or in response to either product safety concerns or as a result of a complaint about a product.

The information included in or with the application is correct

Sponsors of all listed medicines must certify [against sections 26A(2)(k) or 26AB(2)(q) of the Act] that all information included in or with your application is correct.

Additional certifications (if any) 

Sponsors of all listed medicines must certify [against sections 26A(2A) or 26AB(3) of the Act] that your medicine complies with other matters (if any) prescribed by the Regulations. You should regularly refer to the Regulations, as amended time to time, to ensure that you are aware of current requirements.

Conditions of listing

Conditions of listing for listed medicines are imposed under section 28 of the Act. To ensure you are considering the latest version of the Act, see: Therapeutic Goods Act 1989.

Listed medicines are subject to the following conditions (as applicable):

• standard conditions of listing imposed automatically by the Therapeutic Goods (Listed Medicines – Conditions of Listing) Determination 2022 (the Conditions of Listing Determination)
• conditions of listing imposed automatically by sections 28(5), (5B), (6), (7) and (8) of the Act; and
• conditions of listing imposed under the discretionary powers in sections 28(2B) and (3) by the Secretary (of the Department of Health, Disability and Ageing), or their delegate, e.g. product specific conditions.

Important:

Failure to comply with a condition of listing may result in the cancellation of your medicine from the ARTG.

Details about the separate processes for including an AUST L or AUST L(A) listed medicine in the ARTG are set out below.

How to include an AUST L medicine in the ARTG

AUST L medicines are included in the ARTG via a streamlined online listed medicine application and submission portal which is part of the TBS site.

All necessary tools required to lodge, change, and maintain an application for a listed medicine are accessible via TBS. The Listed and assessed listed medicines: Application and submission user guide fully describes the AUST L medicine application and submission process.

Step 1: Obtain access to TBS and the online application portal

To access the application portal, an applicant (who will become the sponsor of the medicine when it is entered in the ARTG) will require a username and password. You must first submit an Organisation details form to obtain a client identification number. Having obtained a client identification number, you can submit a TGA Business Services Access Request Form to become the ‘Business Administrator’ for your company and then can apply for user accounts for yourself and other personnel in your company.

For further information about obtaining a client identification number or gaining access to TBS, contact the TGA by phone 1800 010 624 or email ebs@health.gov.au.

Step 2: Medicine details entered in the TBS application portal

The Listed and assessed listed medicines: Application and submission user guide provides a step-by-step description on how to enter your medicine details.

Step 3: Application passes validation in TBS application portal

During validation, the application and all related sub-documents are checked against the listed medicine business rules. The application must pass validation before it can be submitted to the TGA.

Important:

Successful validation of your application does not mean that the product has been approved by the TGA, nor that the product meets all the requirements for listing.

The TBS application portal is a tool designed to allow electronic submission of an application for a listed medicine. The onus of responsibility is with the sponsor of the medicine to certify, upon submission, that the goods that are the subject of the application meet all the requirements of listing.