EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Repeal of Listing Notices) Notice 2016
The Therapeutic Goods Act 1989 (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, or exported from, Australia. The Act is administered by the Therapeutic Goods Administration (the TGA) within the Department of Health.
Subsection 9A(5) of the Act authorises the Minister to publish a notice in the Gazette or on the Department’s website requiring that specified therapeutic goods be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods, and specifying the conditions subject to which such goods may be included in that part of the Register.
The Therapeutic Goods (Repeal of Listing Notices) Notice 2016 (the Notice) is made under subsection 9A(5) of the Act. The Notice repeals 48 former subsection 9A(5) notices identified in Schedule 1 to the Notice. These notices were made between 2005 and 2015 and are no longer required, due to the making of a succession of determinations under subsection 26BB(1) of the Act (the Permissible Ingredients Determination), which now specify ingredients that may be contained in a medicine listed in the Register under section 26A of the Act, and the requirements in relation to the inclusion of those ingredients in such medicines.
The Notice is a disallowable legislative instrument and commenced on the day after it was registered on the Federal Register of Legislation.
BACKGROUND
Therapeutic goods are required to be included in the Register before being supplied in, imported into, manufactured in or exported from Australia, unless specifically exempted from that requirement or otherwise authorised or approved. Medicines are registered or listed in the relevant part of the Register under Part 3-2 of the Act, depending on the therapeutically active ingredients they contain and the therapeutic claims that are being made.
In general, products that contain low risk therapeutically active ingredients are required to be included in the Part of the Register for listed medicines in Australia, 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 therapeutically active ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.
Prior to the making of the Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015 (the First Permissible Ingredients Determination), which commenced on 1 January 2016, ingredients were authorised for use in listed medicines generally through the list of therapeutic goods in Schedule 4 to the Therapeutic Goods Regulations 1990 or through specific notices made by the Minister under subsection 9A(5) of the Act (Listing Notices). In addition, ingredients or substances that are not listed in a Schedule to the current Poisons Standard, or are excluded from the scope of the Poisons Standard can be ingredients or substances that can be contained in a listed medicine. (The exclusion from the scope of the Poisons Standard could be by way of the concentration of the ingredient or substance in a particular dosage form, or through other requirements.) The Permissible Ingredients Determination now provides for a single, comprehensive list of ingredients permitted for use in listed medicines, along with requirements applying to particular ingredients in the list.
All of the ingredients covered by the repealed notices were included in the First Permissible Ingredients Determination so, since that time, the Listing Notices made under subsection 9A(5) of the Act have been redundant.
CONSULTATION
Extensive consultation was undertaken with industry in 2015 in the lead up to making the the First Permissible Ingredients Determination.
The Office of Best Practice Regulation (OBPR) has advised that this proposal is expected to have minor regulatory impacts on businesses, individuals or community organisations. As the proposal is not going to Cabinet, a Regulation Impact Statement is not required (OBPR Ref. 21218).
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
This statement is prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Therapeutic Goods (Repeal of Listing Notices) Notice 2016
The Therapeutic Goods (Repeal of Listing Notices) Notice 2016 (the 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.
Overview of legislative instrument
The Notice is made under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) by a delegate of the Minister for Health and Aged Care. Subsection 9A(5) of the Act authorises the Minister to publish a notice in the Gazette or on the Department’s website requiring that specified therapeutic goods be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods, and specifying the conditions subject to which such goods may be included in that part of the Register.
The Notice repeals 48 former subsection 9A(5) notices identified in Schedule 1 to the Notice. These notices were made between 2005 and 2015 and are no longer required, due to the making of a succession of determinations under subsection 26BB(1) of the Act (the Permissible Ingredients Determination), which now specify ingredients that may be contained in a medicine listed in the Register under section 26A of the Act, and the requirements in relation to the inclusion of those ingredients in such medicines.
Human rights implications
This instrument does not engage any of the applicable rights or freedoms.
Conclusion
This instrument is compatible with human rights as it does not raise any human rights issues.
Mayada Kayali delegate of the Minister for Health and Aged Care