EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2015 (NO. 3)
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2015 (No. 3) (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 ‘Polaprezinc’ 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). 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 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.
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.
A person can apply for a new ingredient or changes to certain conditions associated with an ingredient 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.
‘Polaprezinc’
‘Polaprezinc’, also known as ‘zinc carnosine,’ is a chelated complex of zinc and L‑carnosine. L-carnosine is a naturally occurring dipeptide consisting of histidine and a non-proteinogenic amino acid (β‑alanine). When orally ingested, Polaprezinc slowly dissociates into zinc and L-carnosine, which are absorbed and utilised by the body.
Polaprezinc has been registered as a medicine in Japan since 1994 for treatment of gastric ulcers, and is available in the US (where it has been available since 2002) and Canada (where it has been available since 2014) as a zinc supplement at doses of 75-150 mg per day (equivalent to 17-34 mg of zinc per day).
Zinc compounds are listed in Schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons:
ZINC COMPOUNDS for human internal use except:
a) in preparations with a recommended daily dose of 25 mg or less of zinc; or
b) in preparations with a recommended daily dose of more than 25 mg but not more than 50 mg of zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.
A review by the TGA of toxicology and clinical studies relating to ‘Polaprezinc’ has concluded that the toxicity of Polaprezinc is low and the incidence of adverse reactions that can be attributed to ‘Polaprezinc’ is also low. The main risk associated with use of Polaprezinc is the potential for zinc-induced copper deficiency, which has been found to occur at daily doses of 50 mg zinc per day or above in healthy populations. This has lead the TGA to accept that Polaprezinc at doses of 111 mg (25 mg per day of zinc) is likely to be safe.
The TGA therefore considers ‘Polaprezinc’ suitable for use in listed medicines, subject to conditions in relation to the maximum allowable dose.
To that end, the delegate of the Minister has determined that therapeutic goods containing ‘Polaprezinc’ as a therapeutically active ingredient can be included in the part of the Register for listed goods, when:
- the preparations contain a recommended daily dose of 25 milligrams or less of zinc; and
- the preparations are for oral use only.
A Compositional Guideline has been prepared by the TGA. It sets out the standards and requirements for the specific forms or types of substances for use in listed medicines where there is no monograph in the British Pharmacopoeia, European Pharmacopoeia or the United States Pharmacopeia – National Formulary in relation to the ingredient in question.
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 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).
The effect of this Listing Notice is that sponsors wishing to use ‘Polaprezinc’ as a therapeutically active ingredient in a medicine can list the medicine on the Register rather than registering it. 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.
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 2015 (No. 3) – ‘Polaprezinc’
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 2015 (No. 3) (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 ‘Polaprezinc’ 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 as a therapeutically active ingredient on 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.
John Skerritt, delegate of the Minister for Health