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This guidance applies to sponsors (product owners) of listed medicines (AUST L) and assessed listed medicines [AUST L(A)]. This guidance is not applicable to medicines that are exclusively for export (i.e. Export only 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:
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 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:
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.
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 The Poisons Standard (the 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 (The 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.
A medicine is listed in the ARTG on the basis of:
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.
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:
For AUST L(A) assessed listed medicines the sponsor certifications are made against:
Details on the required sponsor certifications are provided below.
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.
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.
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.
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.
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
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:
For guidance on advertising medicines, refer to:
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.
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.
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.
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.
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).
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 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:
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 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:
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.
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.
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).
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.
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.
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.
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 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):
Important:
Failure to comply with a condition of listing may result in the cancellation of your medicine from the ARTG.
The Conditions of Listing Determination sets out the standard conditions that will:
Standard conditions are displayed on the listed medicine’s ARTG Certificate and ARTG Record Summary.
The conditions in Part 1 of Schedule 1 to the Conditions of Listing Determination are imposed on all medicines listed in the ARTG under section 26A or 26AE of the Act (i.e. to all AUST L and AUST L(A) medicines).
The conditions of listing (in items 1 to 4 of Part 1 - reproduced below) concern obligations in relation to record keeping and retention, the provision of certain records to the TGA upon request, and the requirement to notify the TGA of certain matters:
1 | The relevant person must keep records relating to the medicine that are necessary to: (a) expedite recall, if necessary, of a batch of the medicine; and (b) identify the manufacturer of each batch of the medicine. |
2 | Where any step in the manufacture of the medicine in Australia is sub‑contracted to a third party, the relevant person must keep copies of relevant Good Manufacturing Practice agreements in relation to that manufacture. |
3 | The relevant person must: (a) retain records of the distribution of the medicine for a period of five years; and (b) upon request, provide the records (or copies of the records) to the TGA. |
4 | The relevant person must notify the TGA of any product recall or other regulatory action taken in relation to the medicine outside Australia, which is or may be relevant to the quality, safety or efficacy of the medicine supplied in Australia, as soon as reasonably practicable after the relevant person becomes aware of the product recall or other regulatory action. |
For information:
‘Relevant person’ is defined in the Therapeutic Goods (Listed Medicines - Conditions of Listing) Determination 2022 as:
in relation to a medicine, means the person in relation to whom the medicine is listed in the Register.
The conditions in Part 2 of Schedule 1 to the Conditions of Listing Determination are imposed on medicines listed in the ARTG under section 26A or 26AE of the Act that are sunscreen preparations mentioned in item 7 of the table in Schedule 4 to the Regulations. In practice, this means AUST L sunscreen preparations that have been tested by AMA laboratories.
The conditions of listing (in item 1 or Part 2) for such listed sunscreen products are:
1. Where testing conducted by AMA Laboratories Inc. is used to substantiate compliance of the medicine with paragraphs (a) and (b) of item 7 of the table in Schedule 4 to the Regulations, the relevant person must:
(a) hold one of the following to scientifically justify the validity and accuracy of the SPF, broad spectrum and water resistance claims for the medicine:
(i) adequate supplementary in-vitro testing data; or
(ii) relevant testing data from an independent testing laboratory on a comparable formulation; or
(iii) other justification acceptable to the TGA; and
(b) provide the information mentioned in paragraph (a) to the TGA within 10 working days of a request by the TGA, or within such other longer period as is agreed with the TGA.
The conditions in Part 3 of Schedule 1 to the Conditions of Listing Determination are imposed on medicines listed under section 26A or 26AE of the Act that contain, or may contain, one or more of certain ingredients (as identified in the Permissible Ingredients Determination), i.e. aristolochic acids.
The relevant ingredients are: Anamirta cocculus; Asarum europaeum; Asarum heterotropoides; asarum oil; Asarum sieboldii; Clematis armandii; Clematis chinensis; Clematis recta; Clematis vitalba; Cocculus orbiculatus; costus root oil; Menispermum canadense; Saussurea costus; Sinomenium actutum; Stephania tetranda.
The conditions of listing (in item 1 of Part 3) for such listed medicines are:
Where testing conducted by AMA Laboratories Inc. is used to substantiate compliance of the medicine with paragraphs (a) and (b) of item 7 of the table in Schedule 4 to the Regulations, the relevant person must:
(a) hold one of the following to scientifically justify the validity and accuracy of the SPF, broad spectrum and water resistance claims for the medicine:
(i) adequate supplementary in-vitro testing data; or
(ii) relevant testing data from an independent testing laboratory on a comparable formulation; or
(iii) other justification acceptable to the TGA; and
(b) provide the information mentioned in paragraph (a) to the TGA within 10 working days of a request by the TGA, or within such other longer period as is agreed with the TGA.
Certain conditions also apply automatically to listed medicines (or some listed medicines) under subsections 28(5), (5B), (6), (7) and (8) of the Act. Further information about particular conditions imposed by these subsections is set out below. You should also refer to section 28 of the Act to see the full text of all conditions that apply automatically by virtue of subsections 28(5), (5B), (6), (7) and (8) - refer to the Act and see below.
Conditions of listing that apply automatically under the Act include those under sections 28(5)(ca) and (e) of the Act and regulation 15A of the Regulations. Under these provisions, sponsors of all listed medicines are required to comply with any record-keeping and reporting requirements set out in the document published by the TGA titled Pharmacovigilance responsibilities of medicine sponsors, as in force from time to time. This includes, but is not limited to, the following reporting requirements, i.e. to notify the TGA of:
Sponsors must meet pharmacovigilance reporting (and record-keeping) requirements for all medicines you have listed in the ARTG regardless of their Australian marketing status (i.e. whether they are currently available for purchase, withdrawn from sale, or otherwise supplied).
Important:
Record-keeping requirements detailed in the ‘Pharmacovigilance Responsibilities of Medicine Sponsors’ include retaining records relating to reporting requirements and safety of your medicine. For listed medicines, these must be retained indefinitely for the life of your medicine and for a period of 5 years after removal from the ARTG.
In addition, sections 29A and 29AA of the Act provide criminal and civil penalties if sponsors of registered or listed goods fail to advise the TGA in writing as soon as they become aware of information that:
Under paragraph 28(5)(aaa) of the Act, if you, as a sponsor, propose to make a change to the information in the ARTG entry for your medicine (e.g. by submitting an application to ‘change a current ARTG entry’) and the information proposed to be changed relates to a certification under s 26A made at the time of listing, the application must be made under section 9D of the Act.
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 subject goods for an indication other than those accepted in relation to the listing of the goods in the ARTG.
Under section 28(5B) of the Act, it is an automatic condition of listing, for all medicines listed under sections 26A or 26AE, 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 medicine is exempt from these requirements (sections 28(5B)(a) and (5C) of the Act).
The automatic condition of listing, for all medicines listed under sections 26A or 26AE also provides 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 (sections 28(5B)(b) and (5C) of the Act).
Under sections 28(6) and (7) of the Act, it is an automatic condition of listing for medicines listed under section 26A of the Act (i.e. AUST L medicines), that sponsors must have evidence to support any claims made for your medicine, or to support indications. Evidence for claims must be held at the time when the claim was made and be retained at all times while your medicine remains listed in the ARTG. Evidence for indications must be held at all times while the medicine remains in the ARTG. You must also provide the evidence for claims or indications to the TGA, if requested, at any time while your medicine remains in the ARTG.
Under section 28(8) of the Act, it is an automatic condition of listing, for medicines listed under section 26AE of the Act (i.e. AUST L(A) medicines), that sponsors have evidence to support indications at all times while the medicine remains in the ARTG, and provide this evidence to the TGA if requested.
Under the legislative framework, specific conditions of listing may also be imposed on listed medicines where this is considered appropriate by the Secretary (or the Secretary’s delegate). These conditions may be imposed, by notice in writing, under section 28(2B) of the Act when the product is first listed in the ARTG - or, be imposed, by notice in writing, under section 28(3) of the Act after the product has been listed in the ARTG.
For example, a product specific condition of listing may potentially be imposed under section 28(2B) at the time of first listing by the delegate in relation to an AUST L(A) medicine.
Information
A condition of listing under section 28(2B) can potentially be imposed for AUST L(A) medicines at the time of listing by a delegate, due to the pre-market assessment of efficacy.
Where a safety concern has been identified for a specific listed medicine at a time after the medicine has been listed in the ARTG, a further condition of listing can be imposed under section 28(3) of the Act to address the concern (e.g. the condition could require certain warning statements on the label of the specific medicine of concern).
As a general position, conditions of listing can be imposed at any time of listing under section 28(2B) of the Act on sponsors who are eligible and wish to use a TGA assessed claim on their assessed listed medicine label. Additional conditions of listing may be imposed some time after the listing under section 28(3) of the Act for eligible sponsors - see Using the TGA assessed claim on medicine labels.
Under section 28(3) of the Act, while a medicine remains listed in the ARTG, new conditions of listing may be imposed and/or existing conditions [that were originally imposed under section 28(2B) or (3)] may be varied or removed, as determined by a delegate of the Secretary. This is done by notice in writing given to the sponsor.
A sponsor may also request that a new condition of listing be imposed or such existing conditions be varied or removed (an application fee may apply: see the ‘Fees and charges: summary’). The delegate of the Secretary will review the request and you will be advised in writing of the decision.
Note, in all cases, the power in section 28(3) to vary or remove existing conditions does not apply to conditions imposed automatically by the Conditions of Listing Determination or by other subsections of section 28 of the Act (apart from section 28(2B) or (3)).
The imposition or variation/removal of a condition under section 28(3) will take effect:
Sponsors are advised in writing of any changes to conditions of listing and you may appeal against a decision under section 28(3) to impose, vary, or remove a condition of listing. Rights of appeal will be advised in the letter from the TGA regarding the change to conditions.
The post-market regulatory framework for listed medicines allows for early market access to low-risk medicines. In facilitating early market access, there is reliance on a risk-based and intel-based system of post-market monitoring and surveillance. The TGA reviews, tests and investigates a proportion of listed medicines for compliance with the regulatory requirements to ensure quality, safety and efficacy.
For more information on the post-market compliance activities for listed medicines, including possible regulatory actions and appeal rights, refer to Understanding listed medicines compliance reviews.
Compliance actions and outcomes may be taken when medicines are found to be non-compliant. This can include market action such as recall, infringement notices being issued and cancellation of the medicine from the ARTG, which means the medicine can no longer be sold in Australia.
The outcomes of post-market compliance activities are routinely published on our website (see Cancellations, Infringement Notices, Listed medicines compliance reports, Database of Recalls, Product Alerts and Product Corrections (DRAC), Alerts, TGA laboratory testing reports, Advertising investigation outcomes).
Refer to Compliance management enforcement for further information.
Subsections 9D(1), (2) and (3) of the Act provide the circumstances under which a sponsor may request a variation (change) to the ARTG entry for your AUST L or AUST L(A) medicine.
For listed medicines, except for applications made under subsection 9D(1) of the Act specifically, variation requests are assessed and processed by the TGA Business Services (TBS) system.
Refer to Changing a listed or an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG) for further information, including about regulatory pathways, other than variation requests, on how to change the information about listed medicines in the ARTG.
Sponsors should also refer to Availability of s 9D(1) pathway to correct information in the ARTG about listed medicines prior to submitting an application under s 9D(1) of the Act, where they identify an error in the ARTG entry for a listed medicine.
All changes to listed medicines (other than those listed for export only) are made via the online listed medicine application and submission portal which is part of the TBS site. Refer to the Listed and assessed listed medicines: Application and submission user guide for more information.
For information on the changes that can be requested for AUST L or AUST L(A) medicines, whether they will incur a fee, and whether they are appropriate as a variation or will result in a separate and distinct good, refer to Changing a listed or an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG).
There is a provision in the application and submission portal to request the same change to be made across several currently listed medicines. Changes to existing listed medicines may result in several outcomes with escalating pricing depending on the significance of changes, which are displayed at the time of validation in a pop-up box. The fees will be applied to each medicine in the multi-change application. Refer to Changing a listed or an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG).
Details about the separate processes for including an AUST L or AUST L(A) listed medicine in the ARTG are set out below.
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.
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.
The Listed and assessed listed medicines: Application and submission user guide provides a step-by-step description on how to enter your medicine details.
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.
If you have problems with your application, you can contact the TGA by email: nonprescriptionmedicines@health.gov.au or by phone: 02 6289 4627.
When the application has passed validation, the sponsor must electronically sign a statutory declaration certifying (as per subsection 26A(2) of the Act) that the application meets the requirements that must be certified, including that the information included in or with the application is correct.
The application can then be submitted in the application portal by the sponsor.
Fees for a listing application are non-refundable and non-transferable and must be paid within 14 days of the application being submitted to the TGA. If payment is not made within 14 days, you will receive an email notifying you that the application has been rejected. Should you wish to continue, you will need to submit a new application (and ensure that the fee is paid).
Once payment is finalised:
The sponsor of the medicine:
A listed medicine may be subject to any number of compliance reviews while it remains in the ARTG. For more information refer to Understanding listed medicines compliance reviews.
For information:
The product details will usually be viewable on the TBS site the day after the information has been recorded in the ARTG.
AUST L(A) medicines are included in the ARTG via a streamlined online listed medicine application and submission portal which is part of the TBS site.
Assessed listed medicines are included in the ARTG following self-certification by the sponsor of the safety and quality of the product, and a TGA assessment of the efficacy evidence supporting the proposed indications. Only products supported by scientific evidence (not evidence of traditional use only) will be accepted for pre-market assessment.
Sponsors must provide the required data and a draft label for the product, which is assessed before your product can be listed. The assessment will include a detailed evaluation of evidence to support proposed intermediate level indications and any lower-level indications to determine if the data supplied adequately supports those indications.
All necessary tools required to lodge, change, and maintain an application for an assessed listed medicine are accessible via TBS.
The Listed and assessed listed medicines: Application and submission user guide describes how to use the TBS site for AUST L(A) medicine applications.
The Completing the application form for an assessed listed medicine describes how to complete the AUST L(A) medicine application form.
The Understanding the application requirements for an assessed listed medicine details on the:
Title changed from 'Quality for listed medicines' to 'Understanding quality requirements for listed medicines' as part of migration to new 'Guidance' content type with:
Information extracted from ARGCM v 8.0 for original publication as below:
Revised introductory paragraph.
Information on proprietary ingredients clarified and a link provided to Supplier assessment, approval and qualification for listed and complementary medicines.
Title changed from 'Quality for listed medicines' to 'Understanding quality requirements for listed medicines' as part of migration to new 'Guidance' content type with:
Information extracted from ARGCM v 8.0 for original publication as below:
Revised introductory paragraph.
Information on proprietary ingredients clarified and a link provided to Supplier assessment, approval and qualification for listed and complementary medicines.
The Department of Health, Disability and Ageing acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.
© Commonwealth of Australia
