EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2013 (NO. 6)
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2013 (No. 6) (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 revoking Therapeutic Goods (Listing) Notice 2008 (No.1), and requiring that therapeutic goods that contain ‘sodium fluoride’ as a therapeutically active ingredient, 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 (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 refer). Medicines are either 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. Part 1 of Schedule 4 does not currently include goods that are oral presentations containing ‘sodium fluoride’ 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 refers).
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 fluoride
Sodium fluoride is a source of fluoride that is widely used in toothpaste products (such as pastes, powders and gels). Its quality is subject to monographs in the British Pharmacopoeia and the United States Pharmacopeia-National Formulary and its safety profile is well established.
In Australia, Therapeutic Goods (Listing) Notice 2008 (No. 1) permitted the use of sodium fluoride as an active ingredient in listed medicines for oral use in toothpaste products subject to certain conditions, including that the concentration of fluoride ion does not exceed 1,000 mg/kg.
In June 2012, amendments to the Poisons Standard came into effect such that topical preparations containing not more than 1,500 mg fluoride ion /kg for both therapeutic and non-therapeutic use became exempt from scheduling requirements subject to label warning requirements for amounts greater than 1,000 mg/kg.
A 2013 TGA review has now determined that the availability of sodium fluoride in listed medicines should be updated to provide consistency with the current scheduling of the substance in the Poisons Standard. The current Listing Notice therefore replaces and revokes Therapeutic Goods (Listing) Notice 2008 (No. 1).
The delegate of the Minister has determined that therapeutic goods containing ‘sodium fluoride’ as a therapeutically active ingredient be included in the part of the Register for listed goods where:
- the preparations are for dental use only; and
- ‘sodium fluoride’ is for use only in pastes, powders or gels for dental hygiene; and
- ‘sodium fluoride’ is in combination with at least one of the therapeutically active ingredients referred to in Item 3, Part 1 of Schedule 4 to the Regulations; and
- the concentration of fluoride ion is not more than 1,500 mg/kg; and
- when the concentration of fluoride ion is more than 1,000 mg/kg, the label for the preparation complies with the requirements of the Required Advisory Statements for Medicine Labels; and
- any claims made regarding the preparation in relation to fluoride content are restricted to those relating to improvements in dental hygiene or the use of fluoride for the prevention of tooth decay.
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.
The effect of this Listing Notice is that sponsors wishing to use sodium fluoride in the formulation of a medicine can list the medicine on the Register rather than registering that medicine. 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 making of the Notice does not involve any new regulatory steps for industry, but rather provides a basis for products containing this ingredient to access the listing process rather than registration, a significant benefit for sponsors.
The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to Listing Notices (OBPR Ref. 14416).
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 set out below.
SUPPLEMENTARY MATERIAL - STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Listing) Notice 2013 (No. 6) – ‘Sodium fluoride’
This 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 Bill/Legislative Instrument
Therapeutic Goods (Listing) Notice 2013 (No. 6) (the 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 effect of the Notice is to allow sponsors of orally ingested therapeutic goods containing ‘sodium fluoride’ as a therapeutically active ingredient to list, rather than register, those goods in the Australian Register of Therapeutic Goods (the Register) (registration being a considerably more expensive and lengthy process than listing). Once the Notice has commenced, persons can apply to list goods containing this ingredient in the Register.
Human rights implications
This legislative instrument does not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
Professor John Skerritt, delegate of the Minister for Health