Standard for the Uniform Scheduling of Medicines and Poisons, No. 4, July 2013. (Published by the Australian Government Under the Therapeutic Goods Act 1989)
(2013; 373 pages)

Resumen

The Poisons Standard is a Legislative Instrument for the purposes of the Legislative Instruments Act 2003. The Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories. The Poisons Standard also includes model provisions about containers and labels, a list of products recommended to be exempt from these provisions, and recommendations about other controls on drugs and poisons.

The Poisons Standard has been presented with a view to promoting uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia.

The Poisons Standard is the legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

The Poisons Standard 2013, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of the decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the National Coordinating Committee on Therapeutic Goods. Further information on the scheduling amendments and the SPF can be accessed at www.tga.gov.au. Refer to Part 1, Interpretation, on page 2 below for definitions of specific terms used in this document including ―medicine‖ and ―poison‖ (noting that the definition of poison includes medicine).

The SUSMP serves two key purposes.

Firstly, the SUSMP contains the decisions of the delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation. Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes.

Secondly, the SUSMP includes model provisions for labelling, containers, storage and possession of poisons in general, which are intended to be adopted for use in each jurisdiction of Australia, according to local requirements and local law. Appropriate labelling and container requirements for products, other than therapeutic goods and agricultural and veterinary chemicals, are imposed through adoption of Parts 1, 2 and 3 of the SUSMP into State or Territory legislation. Other government agencies may also impose controls on certain products, for example cosmetics.

The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling and containers. Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation.

Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP as they are covered by Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)]. Note, however that this exemption does not extend to controls on supply of these poisons.

The SUSMP is presented with a view to promoting uniform:

  • scheduling of poisons throughout Australia;
  • signal headings on labels for poisons throughout Australia;
  • labelling and packaging requirements for poisons throughout Australia;
  • additional controls on the availability and use of poisons in Australia.

The various Commonwealth Acts, legislative instruments and other documents which integrate with the SUSMP include:

  • the Agricultural and Veterinary Chemicals Code Act 1994
  • the Agricultural and Veterinary Chemicals Code Regulations 1995
  • the Therapeutic Goods Act 1989
  • Therapeutic Goods Order 69 – General requirements for labels for medicines
  • Therapeutic Goods Order 80 – Child-Resistant Packaging Requirements for Medicines
  • the Required Advisory Statements for Medicine Labels (RASML).
 
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