Application to amend the Poisons Standard (closed)

Closes 15 Jul 2023

Detailed claims against the requirements of the scheduling criteria

Certain criteria must be taken into account when a decision is made on your scheduling application. These criteria are listed in section 52E of the Therapeutic Goods Act 1989. This includes the scheduling factors detailed in the Scheduling Policy Framework.

Related information

Section 52E criteria

Your application must address the section 52E criteria as fully as available data allows.

Do not leave any of the criteria blank.

In addressing the 52E criteria, you should do so with input from the Scheduling Policy Framework.

In particular, the chapter on the scheduling factors will assist in determining what specific data or other information you need to include with your application and how it applies to your proposal.

For more information, refer to:

a. What are the risks and benefits associated with the use of the substance?

More information

Identify and explain the major risks and benefits of the substance.

Some examples of benefits can be but are not limited to:

  • new drug for the treatment of a disease in humans or animals
  • new insecticide for the control of a pest in crops
  • corrosion inhibitors
b. What are the purposes for which the substance is to be used and the extent of use of the substance?

More information

Include information on the current Australian patterns of use and, if applicable, overseas use patterns.

For example:

  • medical conditions treated and the incidence of these condition(s)
  • the number of people that it would be used to treat
  • other treatments and how they fit into the treatment regiment
  • uses to control certain pest species in crops and how often or widespread the problem is
c. What is the toxicity of the substance?

More information

Insert a discussion of the toxicity of the substance to address the factors set out in the Scheduling Policy Framework under the Chapter on scheduling factors for the Schedules proposed in this application.

We encourage you to include supporting information as an attachment on the 'Supporting data' section of the 'Related documents' page.

d. What is the dosage, formulation, labelling, packaging and presentation of the substance?

More information

Presentation in relation to therapeutic goods means: the way in which therapeutic goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.

As the presentation of the substance may have important safety implications, your application should include the proposed form, strength/concentration and amount in a pack, where applicable.

Specific packaging proposals should also be discussed here. For example, child resistant closures, water soluble bags, closed mixing and loading systems, injector devices, etc.

e. What is the potential for the substance to be misused or abused?

More information

Include information such as reports of overdose, misuse or abuse, whether deliberate or accidental. The potential for conversion of the substance into a Schedule 8 (Controlled Drug) or prohibited substance can be discussed here.

f. Are there any other matters that may be necessary to protect public health?

More information

Include details that you believe are relevant to the decision or about any other matters not covered in questions a. to e. above.

Applicants may wish to highlight the substance's consideration by other national and international regulators, international or AU/NZ standards, UN or WHO policies, conventions, health-based guidance values, etc.

Would you like to provide any other information to support your application to amend the Poisons Standard?