From 5 November 2026 the Poisons and Therapeutic Goods Act and Regulation will be replaced by the:
The information on this webpage applies to the following entities with premises in NSW:
Offences will apply to a person who manufactures or cultivates, possesses, supplies or administers prohibited scheduled substances, prohibited drugs, and prohibited plants without authority to do so.
Licences and authorities previously issued under the Poisons and Therapeutic Goods Act 1966 are changing. The following apply from 5 November 2026:
For the purposes of research, analysis testing, teaching or training, the following substances may be obtained without a licence or authority by a university or research institution that is an AAMRI member, or a NATA accredited laboratory:
If you do not hold NATA accreditation or are not an AAMRI member you must apply for a licence or authority.
To obtain supplies of Schedule 4D, 8, or 9 substances, for the purpose of research, analysis, teaching or training, one of the following is required:
Applicants must have policies and procedures in place to ensure secure storage and authorised access to the substances and plants, and compliance with the Act and the Regulation.
Offences apply if these activities are performed without authorisation.
An obtain licence allows the licence holder to obtain Schedule 4D, 8, and 9 substances from a wholesaler for the purpose of research, analysis, teaching, or training being undertaken by researchers or employees of the licensed institution.
A DMT authority permits an individual, or class of persons, for the purpose of research, analysis, teaching, or training, to:
A DMT Authority can be used to obtain stock from a wholesaler.
A clinical authority is required when an authorised practitioner (such as a medical practitioner) intends to prescribe, supply, or administer a Schedule 9 or Schedule 10 substance for the purpose of conducting a human clinical trial.
For more information on licences and authorities refer to Licences under the Medicines, Poisons and Therapeutic Goods Act and DMT and clinical trial authorities.
Applications for licences and authorities will be available on the Pharmaceutical Services website in late 2026.
Generally, application and annual fees apply to licences and authorities. However, fees may be waived for a university or not-for-profit research institution or organisation.
To have fees waived, you will need to provide evidence of being a university or not-for-profit research institution or organisation.
More information on licence and authority fees is available at:
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The storage of prohibited drugs, and prohibited scheduled substances is outlined in the Medicines Storage Standards.
Universities, research institutions, and laboratories are responsible for keeping a compliant drug register on the premises where Schedule 8, 9, or 10 substances are kept.
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Scheduled substances used for clinical trials must be labelled as per the requirements of Appendix L of the Poisons Standard.
The Act and Regulation outline penalties for offences associated with unauthorised activities.
Penalties are classified in 5 tiers and differ for individuals and corporations. They range from 20 to 400 penalty units for individuals and 100 to 2000 penalty units for corporations.
More information can be found in the Act and the Regulation. Further information on compliance notices and penalties will be published at a later date.
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Further definitions and terminology can be found at key definitions and terminology.
Supporting documents to help understand the requirements of the legislation are available on the Pharmaceutical Services Medicines, Poisons and Therapeutic Goods legislation webpage.
The information on this webpage is provided for general guidance only. While reasonable care has been taken to ensure the accuracy, reliability, and currency of the information, users should refer to the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 for full and current legal requirements.
