Federal Register of Legislation - Australian Government

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Poisons Standard February 2021

Authoritative Version
  • - F2020L01716
  • In force - Superseded Version
  • View Series
Standards/Other as made
This instrument repeals and replaces the Poisons Standard October 2020, principally to incorporate a number of changes to existing entries, and to include a number of specified substances in the Poisons Standard for the first time.
Administered by: Health
Registered 24 Dec 2020
Tabling HistoryDate
Tabled HR02-Feb-2021
Tabled Senate02-Feb-2021

EXPLANATORY STATEMENT

 

Therapeutic Goods Act 1989

 

Poisons Standard February 2021

 

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 also provides a framework for State and Territory governments to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of medicines and poisons in Australia.  The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health.

 

Part 6-3 of the Act (sections 52AA to 52EC) provides the basis for a uniform system of access controls for goods containing scheduled substances.  The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety.  The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse or abuse of, scheduled substances.

 

Subsection 52D(2) of the Act empowers the Secretary to amend the current Poisons Standard or to prepare a document (“a new Poisons Standard”) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.

 

The Poisons Standard reflects decisions of the Secretary or a delegate of the Secretary regarding the classification of medicines and poisons into the different Schedules, signifying the degree of risk and the control recommended to be exercised over their availability to the public.

 

The Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (“ACMS”) (section 52B of the Act refers) and the Advisory Committee on Chemicals Scheduling (“ACCS”) (section 52C of the Act refers), which provide advice and make recommendations to the Secretary on matters relating to medicines and chemicals scheduling decisions.

 

The Schedules contained in the Poisons Standard are incorporated by reference under State and Territory legislation for regulatory purposes.  This enables restrictions to be placed on the supply of scheduled substances to the public, according to the degree of risk associated with the substances and the level of control recommended over their availability, in the interest of public health and safety.

 

Similarly, the Commonwealth takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the Act.  For example, the Act prohibits the publication or broadcasting of advertisements to consumers about prescription medicines containing substances included in Schedule 4 or Schedule 8 to the Poisons Standard, or over-the-counter medicines containing substances included in Schedule 3 and not included in Appendix H of the Poisons Standard.  The advertising of substances included in Schedule 9 or Schedule 10 to the Poisons Standard is also prohibited.

 

The Scheduling Policy Framework (“the SPF”) provides guidance on whether a decision concerning the scheduling of substances under the Poisons Standard would benefit from being referred to ACMS or ACCS for advice.  A copy of the SPF can be found at: https://www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and-chemicals.

 

The purpose of this instrument is to make a new Poisons Standard, the Poisons Standard February 2021, in substitution for the previous Poisons Standard, the Poisons Standard October 2020.

 

The Poisons Standard February 2021 repeals and replaces the Poisons Standard October 2020, principally to incorporate a number of changes to existing entries, and to include a number of specified substances in the Poisons Standard for the first time.

A number of these changes were made following the provision of advice from the ACCS or the ACMS, in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 for amending the Poisons Standard when a proposed amendment is referred to an expert advisory committee.

Public comment was invited in relation to the proposed amendments that were referred to the November 2019 ACMS, March 2020 ACMS, June 2020 ACMS and November 2020 Joint ACMS-ACCS meetings, as follows:

·         the invitation to comment in relation to sumatriptan and zolmitriptan was published on the TGA website on 19 September 2019, with a closing date of 17 October 2019;

·         the invitation to comment in relation to rizatriptan was published on the TGA website on 20 December 2019, with a closing date of 10 February 2020;

·         an invitation to comment in relation to eletriptan, ibuprofen, cumyl-pegaclone and cannabidiol (private applicant proposal) was published on the TGA website on 17 April 2020, with a closing date of 22 May 2020 for the cannabidiol proposal, and a closing date of 18 May 2020 for the eletriptan, ibuprofen and cumyl-pegaclone proposals; and

·         the invitation to comment in relation to cannabidiol (delegate initiated proposal) was published on the TGA website on 24 April 2020, with a closing date of 22 May 2020 (this invitation related to a separate proposal to the proposal mentioned above). A further invitation to comment in relation to both proposals relating to cannabidiol (i.e. both the private application and the delegate initiated proposals in relation to this substance) was published on the TGA website on 9 September 2020, with a closing date of 13 October 2020.

The final decisions were published on the TGA website in relation to:

·         sumatriptan and zolmitriptan on 7 May 2020;

·         rizatriptan on 24 August 2020;

·         eletriptan, ibuprofen and cumyl-pegaclone on 25 November 2020; and

·         cannabidiol (private application and delegate initiated) on 15 December 2020.

The Poisons Standard February 2021 also incorporates a number of minor, delegate-only decisions that were not referred to the ACCS or ACMS including, in particular, a decision to include a new entry in Schedule 4 to the Poisons Standard for SARS-CoV-2 (COVID-19) vaccines, published on the TGA website on 14 December 2020. While Schedule 4 to the Poisons Standard already contains an existing general entry relating to ‘VACCINES for human therapeutic use’, a separate entry specifically mentioning ‘SARS-CoV-2 (COVID-19) vaccine’ is included to highlight the scheduling of such products given their significance as part of the national response to COVID-19 emergency and to ensure consistency with the approach of expressly referring to other vaccines in Schedule 4 (e.g. dengue vaccine, hepatitis A vaccine).

The Poisons Standard February 2021 also incorporates a number of new substances to the Poisons Standard for the first time, including specific entries for cariprazine, bilastine, filgotinib and trifarotene in Schedule 4.

The decisions to make these minor changes and to introduce new substances were delegate-only decisions that were not open to public consultation as the changes were considered, in accordance with the SPF, to be sufficiently straightforward so as to not require consultation.

The Poisons Standard February 2021 is a legislative instrument for the purposes of the Legislation Act 2003. However, section 42 of the Legislation Act 2003 relating to disallowance does not apply (see subsection 52D(4A) of the Act). As a consequence, subsection 9(1) of the Human Rights (Parliamentary Scrutiny) Act 2011 does not require that the instrument be accompanied by a statement of compatibility with the human rights recognised under that Act.

The Poisons Standard February 2021 commences on 1 February 2021.