EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026

The instrument increases fees relating to therapeutic goods to support cost recovery.

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, Disability and Ageing (the Department), is responsible for administering the Act.

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

The main purpose of the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026 (the Amendment Regulations) is to amend the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations), to increase the fees set out in those respective regulations by 4.8% for the 2026-27 financial year. This includes, for example, application fees for the registration of therapeutic goods, application fees for licences to manufacture therapeutic goods and clinical trial notification fees. The increase is made up of an indexation-based increase as well as an additional increase that is necessary to ensure full recovery of the known cost increases to the TGA’s costs-recovered activities in 2026-27.

The Amendment Regulations also amend the MD Regulations to introduce a reduced fee in for certain consent to supply (CTS) applications made to the TGA in relation to non-compliance with Essential Principles that pertain to Unique Device Identification (UDI) requirements, set out in Schedule 1 to the MD Regulations. An application needs to satisfy a number of criteria in order to qualify for the reduced fee. CTS applications are made by medical device sponsors to the TGA and seek the consent of the Secretary to import, supply or export medical devices that do not comply with the Essential Principles. To do so without the consent of the Secretary is an offence under the Act. The Essential Principles are minimum requirements for medical devices, and in 2025, new requirements were introduced into the Essential Principles that relate to unique device identification, or UDI. These requirements will assist with earlier and quicker notification of medical device safety issues to healthcare facilities, healthcare professionals and patients. Deadlines for compliance with UDI requirements are being phased in over a five-year period, beginning 1 July 2026. Following this first compliance deadline, the TGA anticipates receiving a high number of CTS applications in relation to UDI requirements. The TGA has developed a streamlined process for considering such applications, which are reflected in the new reduced fee.

The Amendment Regulations also amend the TG Regulations to close most pathways for accessing nicotine pouches as unapproved therapeutic goods. The Act provides several pathways for accessing unapproved therapeutic goods in limited and specific circumstances. These pathways are intended to address unmet clinical need where approved therapeutic goods are unsuitable or unavailable, and where there is a clear clinical justification for use. The Amendment Regulations close the following pathways for accessing nicotine pouches:

Special Access Scheme Category A and B (SAS A and SAS B) pathways, which allows for the importation and supply of unapproved therapeutic goods by a health practitioner for use in the treatment of particular patients in certain circumstances;
Authorised Prescriber (AP) Scheme pathway, which empowers the Secretary to authorise a medical practitioner to supply a specified therapeutic goods for use in the treatment of a class of patients;
Personal Importation Scheme (PIS) pathway, which allows for the importation of unapproved therapeutic goods for use in the treatment of the importer or their immediate family; and
Extemporaneous compounding pathway, which allows for unapproved medicines to be dispensed, or extemporaneously compounded, for a particular person for a particular therapeutic application to that person.

Details of the Amendment Regulations are set out in the Attachment A. The Amendment Regulations are compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

The Act specifies no conditions that need to be satisfied before the power to make the Amendment Regulations may be exercised. The Amendment Regulations are a legislative instrument for the purposes of the Legislation Act 2003.

The Amendment Regulations commence:

In relation to the updates to fees and the UDI CTS reduced fee pathway—on 1 July 2026; and
In relation to the nicotine pouch amendments—on the 28th day after the Amendment Regulations is registered.

Consultation

In relation to the increases to fees, the TGA undertook public consultation to obtain stakeholder feedback, with a consultation paper released on the TGA website and submissions sought over a three-week period from 6 February 2026 to 27 February 2026. The TGA received 21 submissions. Stakeholders were presented with two options for the annual updates to fees – Option 1 (a 4.8% increase) and Option 2 (a 4.3% increase). Three respondents supported Option 1, and 12 respondents supported Option 2. Six respondents did not support either option, with some arguing for increases to fees to be limited to indexation only or not increased at all. After considering submissions, Option 1 was selected because it was considered critical to ensuring full cost recovery of the costs of administering the therapeutic goods regulatory scheme given rising costs, the need to avoid reducing service delivery to industry, and the efficient operation of the TGA’s activities.

In relation to the UDI CTS reduced fee measures, the TGA undertook a targeted consultation that closed on 30 January 2026. 23 stakeholders responded, including industry bodies such as the Medical Technology Association of Australia and AusBiotech, with the majority supporting the reduced fee approach and streamlined review process. In relation to consultation on the amendments relating to nicotine pouches, the TGA undertook targeted consultation with stakeholders from 27 March to 15 April 2026. The TGA received 24 responses to the consultation. 23 respondents expressed support for the proposal, while one respondent did not support the amendments.

Authority: Subsection 63(1) of the Therapeutic Goods Act 1989

ATTACHMENT A

Details of the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026

Section 1 – Name

This section provides that the title of the Regulations is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026 (the Amendment Regulations).

Section 2 – Commencement

This section provides for the days on which the various parts of the Amendment Regulations commence.

Sections 1 to 4 and anything in the Amendment Regulations not elsewhere covered by this section commence on the day after the Amendment Regulations are registered.

Parts 1 and 2 of Schedule 1 commence on 1 July 2026. These are the amendments that pertain to updates to fees and the reduced fee pathway for UDI CTS applications. Respectively, these amendments commence on 1 July 2026 to align with the beginning of the new financial year and the first compliance deadline for UDI requirements.

Part 3 of Schedule 1 commences on the 28th day after the Amendment Regulation is registered. During this time, regulatory processes will be updated in light of these amendments.

Section 3 – Authority

This section provides that the Amendment Regulations are made under the Therapeutic Goods Act 1989 (the Act).

Section 4 – Schedules

This section provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and that any other item in a Schedule to the instrument has effect according to its terms.

Schedule 1 – Amendments

Part 1—Fees

Part 1 of the Amendment Regulations increases all Therapeutic Goods Administration (TGA) fees by 4.8%, made up of an indexation-based increase and an additional increase. Under subparagraph 63(2)(h) of the Act, the regulations may prescribe fees in respect of matters under the Act, or the regulations made under the Act.

The indexation-based proportion of the increase is calculated using an indexation formula applied to TGA fees and charges in most previous years. The formula averages the Australian Bureau of Statistics’ Consumer Price Index (CPI) and Wage Price Index (WPI). For the year to September 2025, the CPI was 3.2% and the WPI was 3.4%, producing an indexation figure of 3.3%.

An additional increase beyond simple indexation rates is also factored into the final percentage increases to the fees set out in the TG Regulations and the MD Regulations for 2026-27. Each year, the TGA reviews its fees to ensure they are set at appropriate levels and that cost recovery for each therapeutic industry sector is adequate and appropriate. Necessary adjustments are made by considering known cost increases, including annual staff entitlement increases and other cost movements. In 2026-27, the TGA expects the costs of its costs-recovered activities to increase by $11.3 million. To ensure the financial sustainability of the TGA’s costs-recovered activities, it is necessary to fully recover this cost increase for 2026-27. To achieve this, an additional increase of 1.5% for all fees is necessary. This ensures known cost increases to the TGA’s costs-recovered activities—such as application assessments, regulatory compliance and monitoring, and laboratory testing services—are fully recovered, to support the financial sustainability of these activities. The increase in the costs of these activities is mainly driven by rising workforce costs, higher corporate overhead costs and increased laboratory maintenance expenses. This additional increase is added to the above calculated indexation rate to produce a total percentage increase of 4.8% for all TGA fees for 2026-27.

The fees that are prescribed, and that are subject to the increase, are based on the effort involved in processing or undertaking the relevant related service (such as evaluating an application for marketing approval for a prescription medicine) in order to reflect the recovery of the costs of administering the Act, consistent with the Australian Government Cost Recovery Guidelines (the Guidelines).

The Amendment Regulations apply the 4.8% increase to all TGA fees, including for example to: application fees for the registration, listing or inclusion of medicines and biologicals in the Australian Register of Therapeutic Goods (the Register); application fees for licences to manufacture, or to undertake a step in the manufacture of therapeutic goods other than medical devices; fees relating to the evaluation of therapeutic goods for marketing approval; clinical trial notification fees; application fees for export certificates; and inspection fees for manufacturing premises. The updated fees are rounded to the nearest dollar.

The Amendment Regulations complement the Therapeutic Goods (Charges) Amendment (2026 Measures No. 1) Regulations 2026, which increase annual charges for therapeutic goods and licences to manufacture therapeutic goods by up to 6.3% for 2026‑27.

Therapeutic Goods (Medical Devices) Regulations 2002

The Therapeutic Goods (Medical Devices) Regulations 2002 (MD Regulations) provide for a number of matters in relation to the regulation of medical devices, including, relevantly, a schedule of fees relating to applications or requests under the Act in connection with medical devices.

Items [1] and [2] – Subregulation 9.1AA(1), and subregulation 9.1AA(2) (method statement, step 2)

These items amend subregulations 9.1AA(1) and (2) of the MD Regulations to update the figure used for calculating a reduced fee amount that is applicable in certain circumstances set out in paragraph 9.1AA. The figure, which appears in subregulation 9.1AA(1) and the accompanying method statement in subparagraph 9.1AA(2), is updated from $32 to $34 to reflect the 4.8% increase from 1 July 2026.

Item [3] – Paragraph 2.1(b) of Schedule 5

Item 3 amends paragraph 2.1(b) of Schedule 5 to the MD Regulations to update the fee which applies to an assessment that is required to be conducted outside Australia from an hourly rate of $512 to $537, to reflect the 4.8% increase from 1 July 2026.

Item [4] – Amendments of listed provisions—Part 1 of Schedule 5

Item 4 sets out a table of amendments to listed provisions of Part 1 of Schedule 5 to the MD Regulations. The effect of these amendments is to increase the fees for all relevant items by 4.8% from 1 July 2026.

Therapeutic Goods Regulations 1990

The Therapeutic Goods Regulations 1990 (TG Regulations) provide for a number of matters relating to the regulation of therapeutic goods other than medical devices (in practice, principally medicines and biologicals), including, relevantly, schedules of fees relating to applications or requests under the Act in connection with such goods.

Item [5] – Amendments of listed provisions

Item 5 sets out a table of amendments to listed provisions of the TG Regulations.

The effect of these amendments is to increase the fees for all relevant items by 4.8% from 1 July 2026.

Items [6]-[9]– Amendments of listed provisions – clause 3 of Schedule 9, clause 4 of Schedule 9, clause 5 of Schedule 9, and Part 2 of Schedule 9A

Items 6 to 9 set out tables of amendments to listed provisions of the TG Regulations.

The effect of these amendments is to increase the fees for all relevant items by 4.8% from 1 July 2026.

Part 2—Reduced fees

Part 2 of the Amendment Regulations introduces a reduced fee for certain Unique Device Identification (UDI) consent to supply (CTS) applications. Subsection 63(3)(b) of the Act provides that the Governor-General may make regulations providing for the reduction of fees in cases identified in the regulations.

UDI requirements were introduced into the MD Regulations in March 2025 by the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures Regulations 2025 (the 2025 Amendment Regulations), in order to assist with earlier and quicker notification of medical device safety issues to healthcare facilities, healthcare professionals and patients.

The requirements are part of the Essential Principles, which are set out in Schedule 1 to the MD Regulations, and relate to acquiring, and providing with a device, UDI Device Identifiers and UDI Production Identifiers, and including such identifiers, and related information, in the Australian Unique Device Identification Database.

To allow sponsors sufficient time to be able to comply with UDI requirements, the requirements are being introduced over a 5-year phased introduction period, principally based on device risk classes. Under the 2025 Amendment Regulations, the first mandatory deadline for compliance with UDI-related Essential Principles is 1 July 2026 for Class III and Class IIb medical devices.

Under sections 41MA and 41MAA of the Act, it is an offence or civil penalty for a person to import, supply or export a medical device for use in Australia where the device does not comply with the Essential Principles, if the Secretary has not consented to the supply. Persons may apply to the Secretary for such a consent with what is known as a CTS application. Item 1.15 of the table in Part 1 of Schedule 5 to the MD Regulations provides that the fee for such applications is $611 for the first entry in the Register to which the application relates and $123 for each subsequent entry, subject to regulation 9.1AA. Regulation 9.1AA provides for a reduced fee of $34 in certain circumstances which do not relate to UDI requirements.

Some industry stakeholders are not ready to start complying with UDI requirements from the first mandatory compliance deadline of 1 July 2026. This puts the supply of medical devices that are already approved and in the market at risk if sponsors are deterred by the offence and civil penalty provisions in sections 41MA and 41MAA of the Act.

Consequently, the TGA has anticipated receiving a large number of CTS applications in relation to non-compliance with UDI-related Essential Principles (UDI CTS applications) on or after 1 July 2026. As non-compliance with UDI-related Essential Principles is generally considered to be of low risk to the health and safety of patients, the TGA has developed a streamlined approach to manage such applications. To reflect the lower level of effort required of the TGA to process and consider UDI CTS applications, the Amendment Regulations provide for a new reduced fee in regulation 9.1AA of the MD Regulations for applications of this kind. For eligible applications, the reduced fee is $80 for the first entry in the Register to which the application relates, and $10 for each subsequent entry. This reduced fee has been costed by the TGA in accordance with the newly developed streamlined review process for these applications.

Under the Amendment Regulations, a UDI CTS application must satisfy several criteria to qualify for the reduced fee.

Firstly, the application must be made in relation to a “UDI medical device”. This term is defined in the Dictionary section of the MD Regulations and sets out the classes of medical device to which UDI requirements apply.

Secondly, the application must be made solely in relation to non-compliance with Essential Principles that are relevant to UDI requirements. The clauses of Part 2 of Schedule 1 to the MD Regulations that contain UDI-related Essential Principles are clauses 13.5, 13.6, 13A.2(1)(a)(ii), 13A.2(1)(b)(ii), 13C.1, 13C.3, 13C.4 and 13C.5. If an application seeks the consent of the Secretary to import, supply or export a medical device that does not comply with some UDI-related Essential Principles as well as some other Essential Principle that is not UDI-related (e.g. clause 8.3 – Medical devices to be supplied in a sterile state), the applicant is ineligible for the reduced fee and required to pay the full fee of $611. This is appropriate because the assessment of a higher-risk Essential Principle such as clause 8.3 requires additional time and effort on the part of the TGA.

Thirdly, the application must not be made more than 12 months before the mandatory UDI compliance deadline applicable to the medical devices that are the subject of the application. The application provisions at regulation 11.85 of Division 11.24 of the MD Regulations define when the UDI-related requirements introduced by the 2025 Amendment Regulations apply to different classes of medical device, by reference to the “general start day”. The general start day for each class of medical device is defined in the Dictionary section of the MD Regulations. For example, the general start day for Class 4 in vitro diagnostic (IVD) medical devices is 1 July 2028. An application made in relation to a Class 4 IVD medical device before 1 July 2027 does not qualify for the reduced fee. This criterion is intended to ensure that sponsors of medical devices make best efforts to comply with UDI requirements by the standard compliance deadline rather than seeking the Secretary’s consent unduly far in advance of the deadline.

Fourthly, the application must only seek the Secretary’s consent to import, supply or export the non-compliant medical device for a period of no longer than two years. This criterion is intended to prevent sponsors of UDI medical devices from delaying their compliance with UDI requirements beyond what is reasonably necessary to enable them to achieve full compliance. For example, an application made in relation to a Class 4 IVD medical device on 1 July 2027 could only seek the Secretary’s consent for a period ending no later than 1 July 2029 to qualify for the reduced fee.

Finally, the Amendment Regulations also introduce a new eligibility requirement in the existing reduced fee pathway in regulation 9.1AA. This new criterion provides that the CTS application is not otherwise eligible for the UDI CTS reduced fee pathway. This amendment is necessary because it is technically possible for a single CTS application to be eligible for both the existing reduced fee pathway in regulation 9.1AA and the new pathway introduced by the Amendment Regulations. In these circumstances, the new reduced fee pathway for UDI CTS applications applies. This is the appropriate outcome given that the UDI CTS fee structure has been costed in accordance with the newly developed streamlined review process for such applications.

Division 1—Amendments

Therapeutic Goods (Medical Devices) Regulations 2002

Item [10] – Before subregulation 9.1AA(1)

This item inserts a sentence into subregulation 9.1AA which clarifies that the reduced fee pathways in subregulations 9.1AA(1) and 9.1AA(2) are for applications relating to medical devices in certain circumstances. It is necessary to label these two reduced fee pathways because item [12] introduces two new reduced fee pathways for certain CTS applications that relate to UDI requirements, creating a need for each pathway to be appropriately labelled.

Items [11] and [12] – After paragraph 9.1AA(1)(b), and after paragraph 9.1AA(2)(b)

These items insert new paragraph (c) into subregulations 9.1AA(1) and 9.1AA(2) respectively, creating an additional eligibility criterion for the reduced fees set out in those subregulations. The additional criterion for both subregulations is that the application is not of a kind to which the new reduced fee pathways in subregulations 9.1AA(4) and 9.1AA(5) applies, respectively. Without these criteria, it would be possible for a single CTS application to qualify for the existing reduced fee pathways, and the new UDI CTS reduced fee pathways, as both sets of eligibility requirements could capture a CTS application made solely in relation to clause 13A.2 of Part 2 of Schedule 1 to the MD Regulations. This would create uncertainty about which fee is payable in respect of such an application. Paragraphs 9.1AA(1)(c) and 9.1AA(2)(c) avoid this uncertainty by funnelling any application with dual eligibility into the new reduced fee pathway in subregulations 9.1AA(4) or 9.1AA(5), as relevant. This is the appropriate outcome as an application that is eligible for the new reduced fee pathway would be processed under the new streamlined arrangements for UDI CTS applications, and the fee for this pathway is costed in accordance with those arrangements.

Item [13] – Subregulation 9.1AA(3)

This item amends subregulation 9.1AA(3) to clarify that it operates for the purposes of subregulations (1) and (2) of regulation 9.1AA, as opposed to regulation 9.1AA as a whole. Subregulation 9.1AA(3) clarifies the meaning of “affected by the EU transition”, which is a phrase used in the eligibility criteria for the reduced fee pathways in subregulations (1) and (2). Because that phrase is only relevant to the existing reduced fee pathway, and not to the new UDI CTS reduced fee pathway, it is appropriate to clarify that subregulation 9.1AA(3) operates only for the purposes of the former.

Item [14] – At the end of regulation 9.1AA

This item introduces a new reduced fee pathway for certain CTS applications that relate only to non-compliance with UDI-related Essential Principles. The reduced fee is available through two new subregulations: 9.1AA(4) and 9.1AA(5). Two new subregulations cover the two relevant fees in item 1.15 of the table in Part 1 of Schedule 5. The fee in paragraph (a) of item 1.15 is for an application relating to a medical device that is not included in the Register or to a medical device to which a single entry in the Register relates, while the fee in paragraph (b) is for an application that relates to medical devices where there are separate entries in the Register in relation to the devices and the way in which the devices do not comply with the Essential Principles is the same for all the devices.

Subregulation 9.1AA(4) creates a new reduced fee pathway for certain applications covered by paragraph (a) of item 1.15; that is, applications that relate to a maximum of one Register entry. Paragraph (b) provides the criteria that an application has to meet in order to be eligible for this reduced fee. These criteria are:

that the application is made solely in relation to non-compliance with the Essential Principles covered by subregulation (6), which lists all UDI-related Essential Principles;
that the application is not made more than 12 months before the general start day for the device; and
that the application seeks the consent of the Secretary to import, supply or export the device for a period of no longer than 2 years.

If these criteria are met, the subregulation provides that the amount of the application fee is $80.

Subregulation 9.1AA(5) similarly creates a new reduced fee pathway for certain applications covered by paragraph (b) of item 1.15; that is, applications that relate to more than one Register entry. Paragraph (b) provides the criteria that an application has to meet in order to be eligible for this reduced fee, which are the same criteria as subregulation 9.1AA(5). If those criteria are met, the subregulation provides that the amount of the application fee is $80 for the first Register entry to which the devices covered by the application relates, plus $10 for each additional Register entry to which the devices covered by the application relate.

Subregulation 9.1AA(6) lists each of the clauses of Schedule 1 that contain UDI-related Essential Principles. This subregulation is then referenced in the eligibility criteria in subparagraphs 9.1AA(4)(b)(i) and 9.1AA(5)(b(i) that require applications to relate only to UDI-related Essential Principles to be eligible for the reduced fee.

Division 2—Application provisions

Therapeutic Goods (Medical Devices) Regulations 2002

Item [15] – In the appropriate position in Part 11

This item inserts an application provision into Part 11 of the MD Regulations that provides that the amendments of regulation 9.1AA made by Part 2 of Schedule 1 to the Amendment Regulations apply in relation an application for consent made on or after 1 July 2026. This aligns with the first compliance deadline for UDI requirements.

Part 3—Nicotine pouches

Part 3 of the Amendment Regulations closes the main pathways for accessing nicotine pouches as unapproved therapeutic goods under the Act.

‘Unapproved’ is used here to refer to exemptions, approvals or authorisations under the Act or its regulations which permit the importation, exportation, manufacture or supply of therapeutic goods, despite the goods not being entered on the Register. In respect of medicines and other therapeutic goods, the relevant unapproved goods pathways are specified in, for example, subparagraphs 19B(1)(b)(ii) to (v) of the Act.

Subsection 19(8) of the Act provides that the regulations may prescribe the circumstances in which an approval under paragraph 19(1)(a) (known as a ‘Special Access Scheme B’ or ‘SAS B’ approval) or an authorisation under subsection 19(5) (often called an ‘Authorised Prescriber Scheme’ or ‘AP’ authorisation) must not be given. The relevant circumstance may relate to therapeutic goods in a specified class (see subparagraph 19(8)(a)).

Subsection 18(1) of the Act provides that the regulations may exempt specified therapeutic goods from the operation of Part 3-2 of the Act (except sections 31A and sections 31C to 31F). Subregulation 12A(1) of the TG Regulations is made for the purposes of subsection 18(1), and is the legal basis for the TGA’s ‘Special Access Scheme A’ or ‘SAS A’ pathway for medicines. Subregulation 12A(1) currently prescribes all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, as exempt for the purposes of subsection 18(1) of the Act, subject to subregulation 12A(2). Subregulation 12A(2) relevantly provides that an exemption under subregulation 12A(1) is subject to compliance with certain conditions, including that the medicine is to be given to a person who is a ‘Category A patient’. ‘Category A patient’ is defined in subregulation 12A(5) as being a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.

Subregulation 12(1) of the TG Regulations also prescribes therapeutic goods for the purposes of subsection 18(1) of the TG Act, being the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 to the TG Regulations. These goods are exempt from the operation of Part 3-2 of the Act (except sections 30EA, 31A and 31C to 31F).

Table item 1 in Schedule 5 is the legal basis for the TGA’s ‘Personal Importation Scheme’ (PIS) pathway. It provides that therapeutic goods imported for use in the treatment of the importer or the importer’s immediate family are exempt, where certain other criteria prescribed in the item are satisfied. Those matters include that the goods are not any of those specified in paragraph (b) of column 2 of the item. The PIS pathway concerns importation by post, or similar, as well as therapeutic goods carried by a person who arrives in Australia by ship or aeroplane. The latter part of the PIS pathway is sometimes called the ‘traveller’s exemption’.

Table item 6 in Schedule 5 is known as the ‘extemporaneous compounding’ pathway. It provides that medicines that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person are exempt, other than medicines of a kind specified in paragraphs (a), (b) or (c) of column 2 of the item.

Nicotine pouches are small, tobacco-free sachets placed between the lip and gum. They release nicotine, which is absorbed through the lining of the mouth into the bloodstream. Commonly promoted as smoke-free and vapour-free alternatives to smoking or vaping, marketing often emphasises convenience, discretion and flavour variety. Nicotine pouches are distinct from smokeless, oral tobacco products like snus, which are permanently banned under Chapter 4 of the Public Health (Tobacco and Other Products) Act 2023 (Tobacco Act), and have been prohibited from supply in Australia since 1991. Regulation of nicotine pouches is evolving both domestically and internationally. On 5 September 2025, France published a decree banning nicotine pouches and other oral nicotine products. On 28 January 2025, nicotine pouches were declared to be a prohibited product in South Australia, pursuant to subsection 39C(1) of the Tobacco and E-Cigarette Products Act 1997 (SA).

Nicotine pouches are therapeutic goods, including because they have been determined to be therapeutic goods under item 1 of Schedule 1 to the Therapeutic Goods (Determined Goods) Determination 2024 (the 2024 Determination), made under section 7AAA of the Act. That instrument has the effect of determining that goods that contain nicotine and that are for human use are therapeutic goods, other than a small number of specified types of products. At this time, no nicotine pouch product is entered on the Register, and therefore no nicotine pouch product has been comprehensively evaluated by the TGA for quality, safety or efficacy. Nicotine pouches are a therapeutic good which contain nicotine within the entry for nicotine in Schedule 4 (Prescription Only) of the Poisons Standard.

Nicotine is a highly addictive substance. Exposure during adolescence can affect brain development, memory and learning, and increases vulnerability to ongoing nicotine dependence and other substance use. The health and safety risks of nicotine pouches are unknown, and there are concerns that they may pose a range of risks to users. There are limited short-term studies and no robust long-term data on health outcomes. The harms of nicotine are well established, and early data suggests that nicotine pouches may contain high levels of nicotine, which can increase toxicity. Nicotine pouches may also contain undeclared and dangerous ingredients.

Approximately 97% of nicotine pouches imported into Australia are imported and supplied unlawfully, with more than 23 million nicotine pouches seized by the Australian Border Force and the TGA since January 2024. Importantly, there is insufficient high-quality evidence to establish that nicotine pouches are effective in supporting smoking or vaping cessation, or the management of nicotine dependence. The growing availability and promotion of nicotine pouches therefore raises broader public health concerns and risks undermining the objectives of Australia’s tobacco and vaping control reforms.

In addition to the health and safety risks, addressing access to nicotine pouches through the therapeutic goods regulatory framework is an important complementary measure to support the objectives of the TGA’s vaping reforms and to reduce the risk of consumer displacement from vaping goods to other unregulated or emerging nicotine products.

To address these concerns, the Amendment Regulations prevent nicotine pouches from being accessed for use via the above-mentioned access pathways for unapproved therapeutic goods. This approach prioritises public health and safety and reduces community access to this emerging and unregulated nicotine product.

This does not preclude a person from applying to register a nicotine pouch on the Register, or from seeking to use nicotine pouches in a clinical trial in Australia (subject to compliance with requirements under the Act and other applicable laws).

To give effect to this, the Amendment Regulations amend the TG Regulations to:

insert a new definition of “nicotine pouch”;
prescribe that an approval under the SAS B pathway or an authority under the AP Scheme must not be given for nicotine pouches;
amend subregulation 12A(1) to exclude nicotine pouches from the exemption under subsection 18(1) of the Act (SAS A pathway); and
amend items 1 and 6 of Schedule 5 to the TG Regulations to prohibit access to nicotine pouches via the PIS pathway (including the exemption for travellers) and extemporaneous compounding pathway.

Therapeutic Goods Regulations 1990

Item [16] – Regulation 2

This item inserts a new definition of “nicotine pouch” into the TG Regulations.

The definition provides that “nicotine pouch” means a therapeutic good of a kind specified in item 1 of the table in Schedule 1 to the 2024 Determination. The 2024 Determination is made under section 7AAA of the Act and determines that the goods specified in Schedule 1 to that instrument are therapeutic goods for the purposes of the Act.

Item 1 of the table in Schedule 1 refers to goods that contain nicotine and are for human use, other than the following:

tobacco prepared and packed for smoking;
foods that contain naturally occurring nicotine, and do not contain added nicotine (whether natural or synthetic); or
tobacco products which are permanently banned under Chapter 4 of the Public Health (Tobacco and Other Products) Act 2023.

It is appropriate to incorporate this element of the definition by reference to the 2024 Determination as that instrument establishes the basis on which certain nicotine-containing goods (such as vaping goods and nicotine pouches) are regulated as therapeutic goods under the Act. Alignment with the 2024 Determination would ensure consistency across the regulatory framework and captures the relevant exclusions, being products more appropriately regulated under other schemes.

In addition, to fall within the definition of “nicotine pouch”, the good must:

be in the form of a pouch, sachet or other similar article; and
be designed or intended to:
- deliver nicotine by absorption into a person’s bloodstream by being placed in the person’s mouth; and
- remain intact (or relatively intact) in the person’s mouth during usage and be removed after use.

A “pouch, sachet or other similar article” that is “designed or intended to … remain intact (or relatively intact) in the person’s mouth during usage and be removed after use” is intended to encompass a wide range of article forms that are designed or intended to hold, contain or otherwise facilitate the oral delivery of a substance. In addition to pouches and sachets, these articles include for example teabag-style permeable fibre products, but are not intended to include gum. Further, as the nicotine pouch and related nicotine products market is dynamic, this element is intended to capture future developments in the design, manufacture or presentation of these goods.

“Relatively intact” is intended to indicate that, while an article is designed or intended to generally retain its physical form during use, it may nonetheless become opened, weakened, degraded or otherwise altered as a result of use, including through the release of its contents, or mastication by the user.

“Designed or intended to … be removed after use” is intended to reflect that nicotine pouches will generally not be entirely dissolved in the mouth (like a lozenge) or swallowed (like a pill). However, a product is not excluded from the definition of “nicotine pouch” merely because it is capable of being dissolved in the mouth, swallowed or ingested.

The element of “designed or intended to … deliver nicotine by absorption into a person’s bloodstream by being placed in the person’s mouth” is intended to capture a broad array of means of absorption of nicotine, including absorption via the oral mucosa (including buccally via the gums) or in the gastrointestinal system after ingestion.

These additional elements of the definition reflect the typical form and use of nicotine pouches and ensure that the definition appropriately distinguishes such products from other nicotine-containing goods captured by the 2024 Determination.

For the avoidance of doubt, the definition of “nicotine pouch” is intended to cover products containing nicotine (or a derivative, analogue or other structurally or functionally related compound of nicotine):

in any chemical or structural form, including as a free base or salt;
in any amount or concentration;
irrespective of origin, including whether the nicotine is extracted or otherwise derived from tobacco or any other naturally occurring source, or is wholly or partially synthesised;
irrespective of the physical state of the nicotine, including in solid, liquid or other form;
irrespective of the presence or absence of other substances;
irrespective of whether the pouch, sachet or other similar article acts as a container for the nicotine (or any other substance), or whether the nicotine (or any other substance) is infused into or otherwise contained within the material or lining of the article itself.

Item [17] – Subregulation 12A(1)

This item repeals and replaces existing subregulation 12A(1) of the TG Regulations.

Subregulation 12A(1) is the SAS A pathway for medicines, and is made under subsection 18(1) of the Act. Relevantly, subsection 18(1) of the Act provides that the regulations may exempt all therapeutic goods, except those included in a specified class of goods, from the operation of Part 3-2 of the Act (except section 31A and sections 31C to 31F).

Subregulation 12A(1) of the TG Regulations currently provides that all medicines, except those listed in Schedules 9 or 10 to the Poisons Standard, are exempt, subject to subregulation 12A(2). Subregulation 12A(2) sets out the circumstances in which the exemption in subregulation 12A(1) may be accessed, principally where a medicine is to be given to a person who is seriously ill with a condition from which death is likely to occur within a matter of months.

This item repeals and replaces subregulation 12A(1) to preserve its existing effect, save for the addition of nicotine pouches as a class of medicine which is excluded from the operation of the exemption. This excludes nicotine pouches from being accessed via the SAS A pathway.

Item [18] – After regulation 12BA

This item inserts new regulation 12BB into the TG Regulations.

New regulation 12BB is made under subsection 19(8) of the Act. Section 19 of the Act relevantly empowers the Secretary to grant an approval to a person to import, export or supply specified therapeutic goods that are not registered or listed on the Register (under paragraph 19(1)(a)), or to authorise a specified medical practitioner to supply specified therapeutic goods to a specified class of recipients (under subsection 19(5)). Respectively, these powers are often called the SAS B and AP Scheme pathways.

Subsection 19(8) of the Act provides that the regulations may prescribe circumstances in which an approval under paragraph 19(1)(a) or an authority under subsection 19(5) must not be given. Under paragraph 19(8)(a), the prescribed circumstances may relate to therapeutic goods in a specified class.

New subregulation 12BB prescribes a circumstance in which an approval under paragraph 19(1)(a) or an authority under subsection 19(5) must not be given. The circumstance is that the approval or authority relates to nicotine pouches.

This has the effect of preventing access to nicotine pouches via the SAS B or AP Scheme pathways. It also has the effect of preventing access under these pathways to therapeutic goods which have a degree of connection with nicotine pouches, such as an application for a SAS B approval to use another kind of unapproved therapeutic good alongside a nicotine pouch.

Items [19] and [20] - Schedule 5 (table item 1, column 2)

These items add nicotine pouches to the list of therapeutic goods mentioned in paragraph (b) of item 1 of the table in Schedule 5 to the TG Regulations.

Subregulation 12(1) of the TG Regulations relevantly provides that the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of most of Part 3-2 of the Act. This regulation is made under subsection 18(1) of the Act, which provides that the regulations may exempt specified therapeutic goods from the operation of Part 3-2 of the Act (except sections 31A and 31C to 31F).

Item 1 of the table in Schedule 5 to the TG Regulations is often called the ‘Personal Importation Scheme’ or ‘PIS’ pathway. It provides that therapeutic goods imported for use in the treatment of the importer or the importer’s immediate family are exempt, where certain other matters prescribed in the item are satisfied. Those matters relevantly include that the goods are not within any of the classes of therapeutic goods specified in paragraph (b) of column 2 of the item.

These items amend paragraph (b) to include nicotine pouches, with the effect of excluding nicotine pouches from being accessed via the PIS pathway.

The PIS pathway also allows people travelling to Australia as a passenger on a ship or an aeroplane to import unapproved therapeutic goods on their person. This is sometimes called the travellers’ exemption. The inclusion of nicotine pouches in paragraph (b) of item 1 of the table in Schedule 5 means that the traveller’s exemption is not available for nicotine pouches and travellers are not permitted to bring any quantity of nicotine pouches into Australia upon arrival via ship or aeroplane.

Item [21] – Schedule 5 (at the end of the cell at table item 6, column 2)

This item adds nicotine pouches to the list of therapeutic goods mentioned in item 6 of the table in Schedule 5 to the TG Regulations.

Table item 6 in Schedule 5 is often called the ‘extemporaneous compounding’ pathway. It provides that medicines that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person are exempt, other than the classes of medicines excluded by specification in paragraphs (a), (b) or (c) of column 2 of the item.

This item amends item 6 to include nicotine pouches in the list of excluded medicines. As a result, nicotine pouches are not eligible to be supplied under the extemporaneous compounding pathway.

Division 2—Application provisions

Therapeutic Goods Regulations 1990

Item [22] – In the appropriate position in Part 9

This item inserts new Division 30 and section 120 into Part 9 of the TG Regulations, which sets out application provisions clarifying the application of the nicotine pouch amendments. These provisions clarify that the access pathway closures for nicotine pouches apply to the import, export, or supply of nicotine pouches (as relevant), or an application for an approval or an authority in relation to nicotine pouches (as relevant), on or after the commencement of Part 3 of Schedule 1 to the Amendment Regulations, which enacts the closure of the relevant pathways.

Part 3 of Schedule 1 to the Amendment Regulations commences on the 28th day after the Amendment Regulations is registered. During this time, regulatory processes will be updated in light of these amendments.

Subsection 120(1) provides that the amendments to regulation 12A, which exclude nicotine pouches from being accessed via the SAS A pathway, apply in relation to the import, export or supply of a nicotine pouch on or after the commencement of Part 3 of Schedule 1 to the Amendment Regulations.

Subsection 120(2) provides that new regulation 12BB of the TG Regulations, which excludes nicotine pouches from being accessed via the SAS B or AP scheme pathways, applies in relation to an application for an approval or an authority made on or after the commencement of Part 3 of Schedule 1 to the Amendment Regulations.

Subsection 120(3) provides that the amendments to item 1 of Schedule 5 to the TG Regulations, which exclude nicotine pouches from being accessed via the PIS pathway, apply in relation to the import of a nicotine pouch on or after the commencement of Part 3 of Schedule 1 to the Amendment Regulations.

Subsection 120(4) provides that the amendments to item 6 of Schedule 5 to the TG Regulations, which exclude nicotine pouches from being accessed via the extemporaneous compounding pathway, apply in relation to the supply of a nicotine pouch on or after the commencement of Part 3 of Schedule 1 to the Amendment Regulations.

ATTACHMENT B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026

This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

Part 1—Fees

The main purpose of the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026 (the Amendment Regulations) is to amend the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations), to increase the fees set out in those respective regulations by 4.8% for the 2026-27 financial year. The increase is made up of an indexation-based increase as well as an additional increase that is necessary to ensure full recovery of the known cost increases to the TGA’s costs-recovered activities in 2026-27. The indexation-based proportion of the increase is calculated using an indexation formula applied to TGA fees and charges in most previous years. The formula averages the Australian Bureau of Statistics’ Consumer Price Index (CPI) and Wage Price Index (WPI). For the year to September 2025, the CPI was 3.2% and the WPI was 3.4%, producing an indexation figure of 3.3%.

Part 2—Reduced fee for CTS applications in certain circumstances

The Amendment Regulations also amend the MD Regulations to introduce a reduced fee in certain circumstances for consent to supply (CTS) applications made to the TGA in relation to non-compliance with Essential Principles that pertain to Unique Device Identification (UDI) requirements. An application needs to satisfy a number of criteria in order to qualify for the reduced fee.

Consequently, the TGA anticipates receiving a large number of CTS applications in relation to non-compliance with UDI-related Essential Principles (UDI CTS applications) on or after 1 July 2026. As non-compliance with UDI-related Essential Principles is generally considered to be of low risk to the health and safety of patients, the TGA has developed a streamlined approach to manage such applications. To reflect the lower level of effort required of the TGA to process and consider UDI CTS applications, the Amendment Regulations provide for a new reduced fee in regulation 9.1AA of the MD Regulations for applications of this kind. For eligible applications, the reduced fee is $80 for the first entry in the Register to which the application relates, and $10 for each subsequent entry. This reduced fee has been costed by the TGA in accordance with the newly developed streamlined review process for these applications.

Part 3—Nicotine pouches

Part 3 of the Amendment Regulations closes the main pathways for accessing nicotine pouches as unapproved therapeutic goods under the Act.

To give effect to this, the Amendment Regulations amend the TG Regulations to:

insert a new definition of “nicotine pouch”;
prescribe that an approval under the SAS B pathway or an authority under the AP Scheme must not be given for nicotine pouches;
amend subregulation 12A(1) to exclude nicotine pouches from the exemption under subsection 18(1) of the Act (SAS A pathway); and
amend items 1 and 6 of Schedule 5 to the TG Regulations to prohibit access to nicotine pouches via the PIS pathway (including the exemption for travellers) and extemporaneous compounding pathway.

Human rights implications

In relation to the amendments in Parts 1 and 2 that pertain to fees, the Amendment Regulations do not introduce any changes to the TG Regulations or MD Regulations other than to implement the fees-related changes outlined above and as such, they do not engage any of the applicable rights or freedoms.

In relation to the amendments in Part 3 that pertain to nicotine pouches, the Amendment Regulations engage the right to health in Article 12 of the International Covenant on Economic, Social and Cultural Rights (the ICESCR).

The right to health

The Amendment Regulations engage the right to health in Article 12 of the ICESCR. Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standard of physical and mental health and includes an obligation on state parties to take reasonable measures within available resources to progressively secure broader enjoyment of the right.

In General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a ‘fundamental human right indispensable for the exercise of other human rights’, and that the right to health is not to be understood as the right to be health, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.

The Amendment Regulations promote the right to health by seeking to reduce the availability and use of nicotine pouches, which are addictive products associated with a range of short-term health risks and for which the long-term health effects remain uncertain. Evidence of increasing marketing and uptake of these products, particularly by youth and young adults, poses major risks to population health and may undermine established tobacco control measures. By closing lawful importation pathways and restricting access to these products, the Amendment Regulations are directed at preventing nicotine dependence and reducing associated health harms at a population level.

To the extent that the Amendment Regulations may limit individual autonomy in accessing nicotine pouches, any such limitation is reasonable, necessary and proportionate to the legitimate objective of protecting public health. The measures are targeted at products that are unapproved therapeutic goods and are designed to reduce exposure to, and uptake of, potentially harmful and addictive substances, particularly among vulnerable cohorts. The restrictions operate alongside Australia’s broader tobacco control and therapeutic goods regulatory framework, which supports harm minimisation and the safe, regulated availability of nicotine products for therapeutic use where clinically appropriate.

Accordingly, the Amendment Regulations are compatible with the right to health because they advance the protection of public health and are a proportionate response to the identified risks associated with nicotine pouch products.

Conclusion

The Amendment Regulations are compatible with human rights because they maintain and support the right to health in Article 12 of the ICESCR as outlined above, and otherwise do not raise any other human rights issues.

Mark Butler, Minister for Health and Ageing

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026

Administered by Department of Health, Disability and Ageing

Section 4 – Schedules

This section provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and that any other item in a Schedule to the instrument has effect according to its terms.

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Section 4 – Schedules

This section provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and that any other item in a Schedule to the instrument has effect according to its terms.

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