EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Listing) Notice 2010 (No. 1)
Omega-3 fish oil phytosterol esters
OUTLINE
Therapeutic Goods (Listing) Notice 2010 (No. 1) (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 ‘Omega-3 fish oil phytosterol esters’ as an active ingredient in listed medicines for oral use, subject to specified conditions.
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 herbal substances that are for use in listed medicines. Division 3 of Part 5 specifies substances that may be ingredients of preparations, subject to the inclusion of a label advisory statement. At present, Schedule 4 of the Regulations does not include oral preparations that contain ‘Omega-3 fish oil phytosterol esters’ as a therapeutically active ingredient but it is anticipated that it will 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.
Omega-3 fish oil phytosterol esters
‘Omega-3 fish oil phytosterol esters’ is a mixture of phytosterols derived from soybean oil and/or sunflower oil, chemically bound to fatty acids derived from edible marine fish. The fatty acids are enriched in the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).
Oils containing DHA and EPA, such as fish oils and krill oil, are available for use in listed medicines without restriction.
‘Omega-3 fish oil phytosterol esters’ is chemically similar to ‘Phytosterol ester complex – vegetable oil’, which has been available for use in listed medicines since November 2008. This followed a recommendation by the Medicines Evaluation Committee (MEC) at its June 2008 meeting that ‘Phytosterol ester complex – vegetable oil’ is suitable for use as an active ingredient in listed medicines, subject to the required label advisory statements referred to below.
The delegate of the Minister made the Listing Notice, a legislative instrument for the purposes of the Legislative Instrument Act 2003, to provide for ‘Omega-3 fish oil phytosterol esters’ to be used as an active ingredient in oral listed medicines subject to the inclusion of the following advisory statements in the product label, which are required for products containing ‘Phytosterol ester complex – vegetable oil’:
- ‘There is no benefit from taking more than 3g/day of phytosterols from all sources’; and
- ‘Not suitable for pregnant or lactating women’.
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 an accepted standard.
The TGA has prepared the draft Compositional Guideline in relation to ‘Omega-3 fish oil phytosterol esters’, and this will be available on the TGA’s Internet site (www.tga.gov.au) for consultation for six months following the registration of the Listing Notice on the FRLI.
CONSULTATION
The listing of the ingredient ‘Omega-3 fish oil phytosterol esters’ is minor and machinery in nature. As ‘Omega-3 fish oil phytosterol esters’ is similar to ingredients which are currently available for use in listed medicines, this application was not referred to an external evaluation committee.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary in relation to the Listing Notice as the listing of the ingredient ‘Omega-3 fish oil phytosterol esters’ is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.