Federal Register of Legislation - Australian Government

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Poisons Standard Amendment No. 1 of 2012

Authoritative Version
  • - F2012L00943
  • No longer in force
Standards/Other as made
This instrument amends the Poisons Standard 2011.
Administered by: Health
Registered 27 Apr 2012
Tabling HistoryDate
Tabled HR08-May-2012
Tabled Senate10-May-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

 

Poisons Standard Amendment No.1 of 2012

 

The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The TG Act also provides for a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of poisons in Australia.  The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act.

 

Subsection 52D (2) of the TG Act authorises the Secretary to the Department of Health and Ageing, or a delegate of the Secretary, to amend the current Poisons Standard (known as the Standard for the Uniform Scheduling of Medicines and Poisons) 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.

 

Part 6-3 of the TG Act provides for 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.  The TG Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (the ACMS) (section 52B) and the Advisory Committee on Chemicals Scheduling (the ACCS) (section 52C), which provide advice and make recommendations to the Secretary (or a delegate of the Secretary) on matters relating to medicines and chemicals scheduling decisions.  Part 6-3 of the TG Act also provides for the constitution of those committees and other administrative arrangements in relation to the carrying out of their functions in accordance with the regulations.

 

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

 

The purpose of this instrument is to amend the Poisons Standard 2011.  The amendments to the Poisons Standard 2011 set out in Schedule 1 of this instrument consist of decisions made by a delegate of the Secretary.  These amendments commence on 1 May 2012.

 

The Schedules contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes.  The Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the TG Act. For example, the TG Act and Regulations prohibit the publication of advertisements to consumers about prescription medicines included in Schedule 4 or 8 of the Poisons Standard or over the counter medicines included in Schedule 3 and not included in Appendix H of the Poisons Standard. The advertising of substances included in Schedule 9 or Appendix C of the Poisons Standard is also prohibited.

 

The amendments to the Poisons Standard 2011 that are set out in this instrument consist of changes to existing entries and changes to include specified substances in the Poisons Standard for the first time.

 

A number of these changes were made following the provision of advice from the ACMS and the ACCS.  The Scheduling Policy Framework (SPF) provides guidance to assist delegates in making a decision on whether a matter would benefit from being referred to an advisory committee for advice.  A copy of the SPF is available from http://www.tga.gov.au/industry/scheduling-spf.htm.

 

Public comment was invited on those matters referred to the ACMS and the ACCS, which related to proposals to amend the Poisons Standard in relation to the following substances:

 

·         triclosan.  The invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 29 September 2010, and closed on 29 October 2010.  Public submissions were taken into consideration at the December 2010 joint meeting of the ACCS and the ACMS.  Further public comment was subsequently invited on the delegate’s interim decisions on 16 February 2011, with a closing date of 2 March 2011.  The delegate’s final decision in relation to this matter was published on the TGA website on 23 March 2011.  The delegate decided that this decision should be implemented from 1 May 2012, being approximately one year after publication of the final decision to allow formulation changes as necessary and to minimize regulatory impact;

 

·         loperamide.  The invitation to comment in relation to this substance was advertised on the TGA website from 13 April 2011, and closed on 13 May 2011.  Public submissions were taken into consideration at the June 2011 meeting of the ACMS.  Further public comment was subsequently invited on the delegate’s interim decisions on 24 August 2011, with a closing date of 7 September 2011.  The delegate’s final decision in relation to this matter was published on the TGA website on 28 September 2011.  The delegate decided that this decision should be implemented from 1 May 2012, to allow time for companies to manage existing stock; and

 

·         ametoctradin, azelastine, deltamethrin, diclofenac, famciclovir, fluxapyroxad, follistatin, indaziflam, 3,4-methylenedioxypyrovalerone (MDPV), prosulfuron and synthetic cannabinoids (benzoylindoles, cyclohexylphenols, dibenzopyrans, naphthoylindoles, naphthylmethylindoles, naphthoylpyrroles, naphthylmethylindenes, phenylacetylindoles, synthetic cannabinomimetics).  The invitation to comment in relation to these substances was advertised on the TGA website from 10 August 2011, and closed on 7 September 2011.  Public submissions were taken into consideration at the October 2011 meetings of the ACCS and the ACMS.  Further public comment was subsequently invited on the delegate’s interim decisions on 21 December 2011, with a closing date of 13 January 2012.  The delegate’s final decisions in relation to these matters were published on the TGA website on 1 February 2012.  The delegate decided that these decisions should be implemented from 1 May 2012.

 

Other amendments set out in this instrument added the new substances aflibercept, belatacept, ceftaroline fosamil, dapagliflozin, eribulin mesylate, ingenol mebutate, lixisenatide, pitavastatin, rifaximin, taliglucerase alfa, velaglucerase alfa and vemurafenib to the Poisons Standard for the first time..  These decisions were delegate-only decisions that were not open to public consultation, as they were considered to be sufficiently straight forward, in accordance with the guidelines in the SPF, as to not require public consultation.  For some of these previously unscheduled substances, consultation in relation to scheduling was undertaken with the sponsor of the substances.

 

In addition, other amendments set out in this instrument include:  dimethyl sulfoxide, emodepside, laureth carboxylic acids, penthiopyrad and sodium lauryl sulfate.  These decisions were delegate-only decisions that were not open to public consultation as they only related to minor amendments.

 

The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA).  However, section 42 (disallowance) of the LIA does not apply (refer to subsection 52D(4A) of the TG Act).

 

In relation to compatibility with human rights, it is considered that Poisons Standard Amendment No.1 of 2012 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, and a Statement of Compatibility setting that out in further detail is attached.

 

ATTACHMENTS

 

1.         Statement of compatibility for a legislative instrument that does not raise any human rights issues (Poisons Standard Amendment No.1 of 2012).