Therapeutic Goods (Listing) Notice 2012 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L00991 Not in force Legislative Instrument

Select Document

EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2012 (NO. 2)

Magnesium citrate – dibasic tetrahydrate

Subsection 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2012 (No. 2) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).

The Listing Notice has the effect of requiring that therapeutic goods that contain ‘magnesium citrate – dibasic tetrahydrate’ as a therapeutically active ingredient, and that are presented as oral preparations, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.

The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included on the Register before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed on the Register, depending on the ingredients they contain and the therapeutic claims that are being made.

In general, products that contain low risk ingredients are referred to as listed medicines in Australia. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.

Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the Register for listed goods. It does not currently include goods that are oral presentations containing ‘magnesium citrate – dibasic tetrahydrate’ as a therapeutically active ingredient.

Subsection 9A(5) of the Act authorises the Minister for Health to publish a notice in the Commonwealth of Australia Gazette requiring that specified goods be included in the part of the Register for listed goods. Such notices generally require that goods containing particular ingredients be included in that part of the Register. Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.

If Part 1 of Schedule 4 to the Regulations is amended to require goods that are the subject of a subsection 9A(5) notice to be included in the part of the Register for listed goods, the notice ceases to have effect (subsection 9A(6) of the Act).

A person can apply for a new ingredient or substance to be specified in a notice under subsection 9A(5). The TGA evaluates such applications, and the supporting data provided by the applicant, on the basis of safety and quality. The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines and the quality-focussed element characterises the precise and correct nature of the ingredient or substance.

MAGNESIUM CITRATE DIBASIC TETRAHYDRATE

Magnesium is an essential microelement and is used as an active ingredient in products for magnesium supplementation. At present, magnesium citrate - dibasic tetrahydrate is only available for use in registered medicines. A closely related substance, magnesium citrate (anhydrous, nonahydrate and tetradecahydrate forms) is already available for use as an active or excipient ingredient in listed medicines, without restriction. Magnesium citrate - dibasic tetrahydrate differs from the forms of magnesium citrate currently available for use in listed medicines in two respects: it has a lower pH in solution, and different number of waters of hydration.

The TGA evaluated magnesium citrate - dibasic tetrahydrate and concluded that the above differences would have no significant impact on the safety profile of magnesium citrate. The lower pH of magnesium citrate - dibasic tetrahydrate in solution, for example, is consistent with the typical pH of soft drinks.

The delegate of the Minister has determined that therapeutic goods containing magnesium citrate - dibasic tetrahydrate as a therapeutically active ingredient be included in the part of the Register for listed goods when such goods are oral preparations.

The TGA has prepared a physico-chemical description of magnesium citrate – dibasic tetrahydrate in the form of a draft Compositional Guideline. Compositional guidelines are intended to assist applicants for the listing of therapeutic goods in the Register that are or that include goods of a kind described in a listing notice in identifying the specific forms or types of ingredients or substances where, as in this case, there is no standard in the British Pharmacopoeia, United States Pharmacopoeia or European Pharmacopoeia in relation to the ingredient or substance in question. This draft Compositional Guideline will be available on the TGA’s website (www.tga.gov.au) for consultation for six weeks following the registration of the Listing Notice on FRLI. The guideline will then be published on the website in its final form.

CONSULTATION

Consultation was not undertaken in relation to the making of the Listing Notice, as the notice is considered to be minor and machinery in nature, with low compliance costs for affected industry.

Given its eligibility for use in listed medicines, sponsors wishing to use magnesium citrate – dibasic tetrahydrate in the formulation of relevant products will not need to make an application for a new registered medicine on the basis of this ingredient being present. Applications for new registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to inclusion on the Register, a process that is considerably more expensive and lengthy than the listing process.

The Office of Best Practice Regulation (OBPR) has confirmed that a regulatory impact statement was not required in relation to the Listing Notice (OBPR ref. 13279).

In relation to compatibility with human rights, it is considered that the Listing Notice 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, and a Statement of Compatibility setting that out in further detail is attached.

ATTACHMENTS

1. Statement of compatibility for a legislative instrument that does not raise any human rights issues (Therapeutic Goods (Listing) Notice 2012 (No.2) – Magnesium citrate – dibasic tetrahydrate).

Overview

The Therapeutic Goods (Listing) Notice 2012 (No. 2) was enacted to address a specific regulatory gap concerning the listing of therapeutic goods containing magnesium citrate – dibasic tetrahydrate as an active ingredient, particularly when presented as oral preparations. This notice, made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989, aims to ensure that these goods are included in the Australian Register of Therapeutic Goods (ARTG) for listed medicines. The Therapeutic Goods Administration (TGA) is responsible for administering the Act, which oversees the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. The notice aims to streamline the process for including such products in the ARTG by specifying that magnesium citrate – dibasic tetrahydrate, despite its differences from other forms of magnesium citrate, is considered safe for use in listed medicines. This measure is intended to facilitate the availability of magnesium citrate – dibasic tetrahydrate in oral preparations while maintaining stringent regulatory standards.

Scope and Application

The Therapeutic Goods (Listing) Notice 2012 (No. 2) is a legislative instrument made under subsection 9A(5) of the Therapeutic Goods Act 1989, which pertains to the regulation and control of therapeutic goods in Australia. This notice specifically mandates the inclusion of oral preparations containing magnesium citrate – dibasic tetrahydrate as a therapeutically active ingredient in the Australian Register of Therapeutic Goods (ARTG) for listed goods. The primary aim of this legislative instrument is to ensure that these therapeutic goods, which are considered relatively low risk, meet the necessary safety and quality standards before being supplied, imported, manufactured, or exported within Australia. The notice came into effect on the day following its registration on the Federal Register of Legislative Instruments. The scope of the notice extends to all entities and individuals involved in the supply, importation, manufacture, or export of oral preparations containing magnesium citrate – dibasic tetrahydrate in Australia, thereby ensuring that these products comply with the national standards set forth by the Therapeutic Goods Administration (TGA). The notice does not exempt any specific industries or transactions, and its application is nationwide, covering the entire Commonwealth of Australia. While the notice itself does not explicitly state exclusions, exemptions, or specific thresholds, the broader framework provided by the Therapeutic Goods Act 1989 and its associated regulations may offer certain exclusions or exemptions. Additionally, the Therapeutic Goods Regulations 1990 and any subordinate instruments can further extend or restrict the application of this notice.

Key Provisions

The Therapeutic Goods (Listing) Notice 2012 (No. 2) (the Listing Notice), made under subsection 9A(5) of the Therapeutic Goods Act 1989, mandates that therapeutic goods containing 'magnesium citrate – dibasic tetrahydrate' as a therapeutically active ingredient and presented as oral preparations must be included in the part of the Australian Register of Therapeutic Goods (the Register) designated for listed goods (subsection 9A(5)). This requirement commenced on the day after the Listing Notice was registered on the Federal Register of Legislative Instruments (FRLI). The Act mandates that therapeutic goods must be included on the Register before being supplied in, imported into, manufactured in, or exported from Australia (sections 19B and 19D of the Act). The Therapeutic Goods Administration (TGA) is responsible for administering the Act and oversees the inclusion of goods on the Register, which is divided into registered and listed goods based on ingredients and therapeutic claims. Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 specifies the therapeutic goods that must be included in the Register for listed goods, but it did not previously include oral preparations containing magnesium citrate – dibasic tetrahydrate. The Listing Notice imposes the obligation on relevant parties to ensure that therapeutic goods containing magnesium citrate – dibasic tetrahydrate as a therapeutically active ingredient, when presented as oral preparations, are included on the Register for listed goods. Sponsors of these products must comply with the requirements set out in the Listing Notice and any applicable guidelines provided by the TGA, such as the draft Compositional Guideline available for consultation on the TGA’s website. The TGA evaluates the safety and quality of the ingredients to determine their suitability for inclusion in listed medicines. Failure to comply with the requirements of the Listing Notice may result in legal consequences. Section 31 of the Therapeutic Goods Act 1989 provides for the imposition of civil penalties for non-compliance with the Act, including listing requirements. The maximum penalty for contravening section 31 is generally determined by the seriousness of the contravention, with penalties that can include fines up to $222,200 for individuals and $1,111,000 for bodies corporate, depending on the specific circumstances and repeat offending. Additionally, under section 33, the TGA can take enforcement actions such as issuing infringement notices or seeking court orders to address non-compliance, further reinforcing the importance of adhering to the Listing Notice.

Area of Law: Medical Law
Instrument: Notice
Concepts: Definitions & Interpretation; Regulatory Standards; Compliance Obligations

Interactions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

Legislation content