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Research and analytical laboratories using scheduled substances

Persons who hold a general approval to use regulated poisons for non-therapeutic purposes (e.g. research, teaching or analysis) for research or analytical purposes in a non-university laboratory setting can continue to hold an approval under the Medicines and Poisons Act 2019 (MPA).  The MPA replaced the Health (Drugs and Poisons) Regulation 1996 (HDPR) on 27 September 2021.

New general approvals to use regulated poisons will be issued under the MPA.

Types of poisons

Regulated poisons include S2, S3, S4, S7 and S8 poisons when not used or intended to be used for therapeutic purposes and prohibited substances (S9 and S10 substances).

S8, S9 and S10 substances used for non-therapeutic purposes are classed as high-risk poisons. Users of high-risk poisons will be required to keep a high-risk poison register to record all dealings with theses poisons from purchase to disposal.

General approvals

A general approval is required to deal (buy, possess, use and dispose) with regulated poisons, other than non-restricted S7 poisons, for non-therapeutic purposes. Restricted S7 (RS7) poisons are prescribed in schedule 1 of the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 (the Poisons Regulation).

There are no fees associated with obtaining a general approval.

Authorisations under the HDPR will transition as closely as possible to a new authority under the MPA. The authority holder may apply for an amendment to their authority to add additional substances.

Apply for a general approval

You can apply for a general approval to use regulated poisons for non-therapeutic purposes for research or analytical purposes in a non-university laboratory by using Poisons general approvals application forms and fees.

There are no fees associated with obtaining a general approval.

Exemptions for reference materials

Under the Poisons Regulation the analytical reference materials are exempt from requiring an authority due to the low risk associated with their use.

Persons using reference materials in analytical laboratories may purchase and use reference materials containing up to 1 g of regulated poisons without an approval. The reference materials must be manufactured by an accredited laboratory as specified in section 13 of the Poisons Regulation.

Substance management plans (SMPs)

A general approval holder who operates at multiple sites, or who deals with high-risk poisons, will require a substance management plan (SMP). An SMP is a document that identifies and addresses the risks associated with carrying out regulated activities.

The SMP must comply with the Departmental standard - Substance management plans for regulated poisons (PDF 283 kB). Substance Management Plan Checklist – research, analysis & teaching (DOCX 621 kB) is available to assist the development of an SMP.

General approval holders have until 26 September 2022 to prepare and implement SMPs.

Requirements for general approval holders

The Poisons Regulation requires the general approval holder to implement measures to ensure that the purchase, possession, application (use), transport and disposal of regulated poisons are undertaken in a safe and secure manner.

Storage and safety

Storage and transport of regulated poisons must be undertaken in a manner which ensures that access is restricted to persons authorised by the authority holder.

The Poisons Regulation requires authority holders for high risk poisons to implement measures to ensure the purchase, storage and transport of such poisons is undertaken in a safe and secure manner and is restricted to persons authorised under the SMP. Additional physical or electronic security measures are also required for high-risk poisons.

Disposal of waste

The Poisons Regulation requires that waste from high-risk poison is destroyed under the supervision of an inspector under the MPA or another person authorised by the chief executive.

Regulated poisons must be disposed of in a way that is lawful under the Environmental Protection Act 1994 or by giving the waste to a person authorised under a substance authority to dispose of it.

Any RS7 and high-risk poison losses or releases causing or likely to cause a person to require medical attention must be reported to the chief executive as soon as possible, but within seven days.

Purchase orders

Wholesale buyers of regulated poisons must give a purchase order to the supplier, including information demonstrating authority to possess the poison. Purchase orders must meet specific verification and security criteria and buyers of high-risk poisons must notify the supplier when they have received the poison.

Register

A High-Risk Poison Register, which records all dealings in relation to high-risk poisons, must be established. The High-Risk Poison Register may be electronic or paper based and must include details (e.g. date, name, form, strength and amount of poison, nature of dealing) to be able to reconcile the amount of poison received, applied, supplied or disposed of.

Record keeping

Records such as purchase orders, invoices, disposal of high-risk poisons must be kept for five years.

Related information

Departmental standards

Last updated: 24 September 2021