EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2009 (No. 2)
Sodium citrate and sodium acid citrate
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2009 (No. 2) (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 sodium citrate and sodium acid citrate as active ingredients in Listed medicines for oral use.
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 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.
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. At present, Schedule 4 of the Regulations does not include reference to sodium citrate or sodium acid citrate as active ingredients for oral medicines.
In order to facilitate the timely approval of new listable therapeutic goods, subsection 9A(5) of the Act allows the Minister for Health and Ageing 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.
Sodium citrate and sodium acid citrate are currently only permitted for use as excipients in Listed medicines. A number of other citrate salts are permitted as both active and excipient ingredients in Listed medicines. Citric acid anhydrous and citric acid monohydrate are also approved use as active ingredients in Listed medicines.
The available information on the safety and toxicity of citrate salts is limited, but indicates that citrate salts are substances of relatively low toxicity when administered via the oral route.
At its meeting in March 2009, the Complementary Medicines Evaluation Committee (CMEC) noted that sodium citrate and sodium acid citrate, previously permitted only for use as excipients in Listed medicines, would also be permitted for use as active ingredients in Listed medicines.
The Listing Notice provides for sodium citrate and sodium acid citrate to be used as active ingredients in oral Listed medicines.
CONSULTATION
Although the listing of sodium citrate and sodium acid citrate as active ingredients in Listed medicines for oral use is minor and machinery in nature, the CMEC was consulted during the approval process for this ingredient.