EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Listing) Notice 2009 (No. 8)
Trefriw Wells mineral water
OUTLINE
Therapeutic Goods (Listing) Notice 2009 (No. 8) (the Listing Notice) is a Notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice has the effect of permitting the use of Trefriw Wells mineral water as an active ingredient in listed medicines for oral use when presented in single use sachets for therapeutic use as an iron supplement.
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 in the Australian Register of Therapeutic Goods (the ARTG) before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.
In Australia, products that contain low risk ingredients are referred to as listed medicines. 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.
Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the ARTG for listed medicines. Part 5 of Schedule 4 specifies substances other than vitamins, minerals and plant material that are for use in listed medicines. Division 1 of Part 5 specifies substances not mentioned in Divisions 2 or 3 that may be ingredients of preparations. At present, Schedule 4 of the Regulations does not include a reference to Trefriw Wells mineral water but it is anticipated that Division 1 of Part 5 of Schedule 4 of the Regulations will include a reference to Trefriw Wells mineral water when the Regulations are next amended.
In order to facilitate the timely approval of new listable therapeutic goods, subsection 9A(5) of the Act allows the Minister for Health to publish a listing notice that has the effect of permitting the use of particular therapeutic goods in listed medicines subject to any specified conditions.
Pursuant to subsection 9A(6) of the Act, if Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of a listing notice, that listing notice ceases to have effect.
Trefriw Wells mineral water
Trefriw Wells mineral water is a clear, naturally occurring mineral water sourced from Trefriw Wells Spa, North Wales, United Kingdom (UK) that is claimed to contain iron at a concentration of approximately 200 mg/L, and at least 25 other metals, including relatively high levels of aluminium, manganese, sulphate and nickel. The drinking of the waters from Trefriw Wells Spa for therapeutic benefit dates from the first half of the 19th century to the present day. Currently the water from Trefriw Wells Spa, sold under the name of Spatone, is sold in Australia and overseas. Spatone is sold as a single dose sachet of 25 mL, which contains approximately 5 mg of iron.
No adverse reactions in Australia were identified in the Office of Medicines Safety Monitoring database for Trefriw Wells mineral water. Twenty four adverse reactions from recent sales of Spatone in several countries, including Australia, have been reported to the UK owners, and were predominantly minor in nature. There are no safety concerns relating to the levels of aluminium, manganese, sulphate and nickel in the product.
The Complementary Medicines Evaluation Committee (CMEC) is a statutory committee established under subsection 52G(1) of the Act which gives scientific and policy advice to the Minister for Health and Ageing and the Secretary to the Department of Health and Ageing regarding controls on the supply and use of complementary listed medicines, with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products.
In February 2008, the CMEC recommended approval of a mineral water from a specified source in Trefriw Wells, North Wales (subsequently allocated the Australian Approved Name of Trefriw Wells mineral water) as being suitable for use as an ingredient in listed therapeutic goods, subject to the resolution of the outstanding quality issues.
As these issues have been satisfactorily addressed, preparations for oral use containing Trefriw Wells mineral water, which has been defined as ‘a naturally-occurring mineral water that is sourced from Trefriw Wells Spa, North Wales, United Kingdom’, have been approved for use as an active ingredient in oral listed medicines when presented in single use sachets for therapeutic use as an iron supplement.
Draft Compositional Guidelines are prepared by the TGA and intended to set 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 (BP) or other acceptable monograph.
The TGA has prepared draft Compositional Guidelines in relation to Trefriw Wells mineral water and these will be available on the TGA’s web site (www.tga.gov.au) for consultation for six months following the registration of the Listing Notice on the FRLI.
CONSULTATION
Although the listing of the preparation Trefriw Wells mineral water is minor and machinery in nature, the CMEC was consulted during the approval process for this preparation.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary in relation to the Listing Notice as the listing of the preparation Trefriw Wells mineral water is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.