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Scheduling of medicines & poisons

If you have an enquiry about scheduling of medicines or poisons that is not answered by this website, please see the contact details below.

Scheduling amendments

State/Territory scheduling information

Background

Scheduling is a national classification system that controls how medicines and chemicals are made available to the public. Medicines and chemicals are classified into Schedules according to the level of regulatory control over the availability of the medicine or chemical, required to protect public health and safety. The Schedules are

  • Schedule 1 Not currently in use
  • Schedule 2 Pharmacy Medicine
  • Schedule 3 Pharmacist Only Medicine
  • Schedule 4 Prescription Only Medicine OR Prescription Animal Remedy
  • Schedule 5 Caution
  • Schedule 6 Poison
  • Schedule 7 Dangerous Poison
  • Schedule 8 Controlled Drug
  • Schedule 9 Prohibited Substance

The Schedules are published in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and are given legal effect through state and territory legislation. The SUSDP is legally referred to as the Poisons Standard.

Medicines and Poisons scheduling from 1 July 2010

Revised scheduling arrangements for medicines and chemicals take effect on 1 July 2010. The details of the new arrangements can be found in the Scheduling Policy Framework <http://www.tga.gov.au/regulation/scheduling-policy-framework.htm> and are summarised in the following flowcharts:

The changes include:

  • the National Drugs and Poisons Schedule Committee (NDPSC) will be replaced by the Secretary of the Department of Health and Ageing (DoHA) - or her delegate - as the decision maker for the scheduling of medicines and chemicals;
  • two new expert advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, will be established to provide advice and make recommendations to the Secretary (or delegate) on medicines and chemicals scheduling decisions;
  • a single Secretariat, supporting both Advisory Committees, will ensure ongoing consistency and cohesiveness of processes and decisions; and
  • closer integration of the revised scheduling arrangements with existing Commonwealth evaluation and product registration schemes.

In addition the Poisons Standard <http://www.tga.gov.au/ndpsc/susdp.htm>, at present named the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) will be renamed the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), which will be available from 1 September 2010.

The changes aim to improve the efficiency and timeliness of scheduling decisions, while maintaining the existing high level of scheduling uniformity across Australian states and territories.

The Therapeutic Goods Administration, the Office of Health Protection, the Australian Pesticides and Veterinary Medicines Authority and the National Industrial Chemicals Notification and Assessment Scheme are working together to develop and implement these revised arrangements for medicines and chemicals scheduling.

The revised scheduling arrangements have been endorsed by the Australian Health Ministers' Conference (AHMC) and the Council of Australian Governments. Further information regarding the background to these changes can be found at: Revised medicines and chemicals scheduling arrangements <http://www.tga.gov.au/ndpsc/scheduling-revised.htm>.

Scheduling legislation

The legislation under which the scheduling framework operates may be accessed through the following links to the Attorney-General's Department's ComLaw website <http://www.comlaw.gov.au>:

Contact details for enquiries about scheduling of medicines or poisons

If your enquiry is not specifically about scheduling of medicines or poisons, see: Contact the TGA <http://www.tga.gov.au/contact.htm>

Medicines & Poisons Scheduling Secretariat

  • Email:
  • Phone:
    • 02 6289 2584
    • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
      • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
      • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
  • Fax: 02 6289 2500
  • Post: The Secretary, Medicines & Poisons Scheduling, PO Box 9848, Canberra ACT 2601, Australia
  • Street address (for deliveries): The Secretary, Medicines & Poisons Scheduling, MDP88, Level 5, Scarborough House, Atlantic St, Woden ACT 2606, Australia

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