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).