EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2012 (NO. 1)
Sodium molybdate dihydrate
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2012 (No. 1) (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 ‘sodium molybdate dihydrate’ as a therapeutically active ingredient in listed medicines, subject to certain conditions, 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.
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 preparations containing sodium molybdate dihydrate 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.
SODIUM MOLYBDATE DIHYDRATE
Molybdenum (Mo) is an essential microelement, a deficiency of which has the potential to have serious health consequences. It is present in a typical human diet with levels of daily intake being dependent on levels in the soil and in drinking water. At present, sodium molybdate dihydrate is only available for use in registered medicines. However, there are two other substances containing Mo that are permitted for use as ingredients in listed medicines: ‘Molybdenum trioxide’ (Mo trioxide) and ‘Yeast-high molybdenum’.
In 2002, the TGA evaluated Mo trioxide as a proposed new substance for use in complementary medicines. The evaluation report concluded that compounds such as sodium molybdate dihydrate and Mo trioxide have equivalent safety profiles and the Complementary Medicines Evaluation Committee (CMEC) recommended that Mo trioxide would be suitable for use as an active ingredient in listed therapeutic goods, with a limit on the maximum daily dose of 125 μg Mo.
The TGA has now conducted a comprehensive search of the literature published since the evaluation of Mo trioxide in 2002. This search did not retrieve any new safety data that would alter the previous conclusions about the safety of Mo. However, data from a recently published study on the fate of Mo in the human body were consistent with the previously adopted maximum daily dose limit of 125 μg/day.
The delegate of the Minister has determined that therapeutic goods containing sodium molybdate dihydrate as a therapeutically active ingredient be included in the part of the Register for listed goods, when the goods are oral preparations and a maximum daily dose of the goods will provide no more than 125 μg Mo. These preparations will provide an adequate supplemental dose of Mo and provide an adequate safety margin in combination with a typical Australian dietary intake of Mo.
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 sodium molybdate dihydrate 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. 13277).
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.1) – Sodium molybdate dihydrate).