From 5 November 2026, the Poisons and Therapeutic Goods Act 1966 and Poisons and Therapeutic Goods Regulation 2008 will be replaced respectively by the:
The objectives of the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 are to:
The Act allows the NSW Health Secretary to make a standard or policy directive about carrying out a regulated activity with a regulated substance.
Standards set out requirements, specifications and procedures for regulated medicines or related activities, ensuring their safety, consistency, and reliability. The following standards have been developed under the Act:
A Ministry of Health policy directive contains material that must be implemented across NSW Health as a part of ongoing operations. Compliance with policy directives within NSW Health is mandatory.
The following Policy Directives apply to NSW public health entities' medicines:
[back to top]
This legislation applies to any person or organisation involved in the handling, obtaining, prescribing, supply, distribution, storage, administration or use of medicines, poisons, restricted substances and therapeutic goods in NSW.
These persons and organisations are listed below.
This includes pharmacists, medical practitioners, nurse practitioners, midwife practitioners, dentists, veterinary practitioners, optometrists, podiatrists, and nurses.
Public health entities including:
Private health facilities
A private health facility, within the meaning of the Act, is one licensed under the Private Health Facilities Act 2007. A list of licensed facilities can be found at Private health facilities.
Health services such as:
All individuals or entities that wholesale or retail supply scheduled medicines and Schedule 7J poisons must have a licence to carry out this activity.
Clinic owners and health practitioners who obtain, prescribe, supply and administer cosmetic use substances.
Certain businesses that supply nitrous oxide products must comply with restrictions on retail sales, purchase limits, sales hours, online delivery, product storage and recordkeeping requirements. More information is available on the Nitrous oxide regulation webpage.
Persons who obtain and use scheduled medicines, prohibited drugs, prohibited scheduled substances and prohibited plants for the purpose of research, analysis, testing, teaching or training.
The Act provides three main forms of authorisation: approvals, licences and authorities. These authorisations regulate who can carry out specific activities involving medicines and poisons.
A licence is an authorisation under the Act required for a business or individual to undertake the activities of obtaining, supplying by wholesale, supplying, or selling Schedule 2, 3, 4, 7J, 8 and 9 substances.
Licences issued under the Act include wholesale, retail, and obtain licences.
For more information, see Licences under the Medicines, Poisons and Therapeutic Goods Act 2022.
A prescriber may require approval under the Act to prescribe, supply or administer certain high-risk scheduled medicines. The approval is issued by NSW Health. For more information on approvals and any exemptions, see Medicine approvals.
Authorities issued under the Act include:
For more information, see Authorities - DMT and clinical trials.
[back to top]
There are a number of reporting and notification obligations that apply under these laws. These include:
The Act and Regulation set out offences and maximum penalties associated with unauthorised activities. These can be found in the Act at Offences and penalties.
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 Part 6.2 Offences and penalties of the Act and Schedule 3 of the Regulation.
Authorised officers or NSW Health Pharmaceutical Services inspectors, can issue penalty notices to persons that commit a penalty notice offence under the Act or the Regulation. Penalty notices that are issued comply with the Fines Act 1996.
[back to top]
Refer to Schedule 3 of the Act and Schedule 4 of the Regulation for definitions of key terminology that apply to this legislation.
Under the Medicines, Poisons and Therapeutic Goods Regulation 2026, ‘substance dependence’ means:
The ICD-11 and DSM-5 both define substance dependence as a compulsive pattern of substance use that leads to significant impairment or distress.
Substance dependence is characterized by impaired control, social impairment risky use, and physiological dependence (tolerance or withdrawal), with continued use despite negative consequences and a strong compulsion to prioritize substance use over other responsibilities. For more information on substance dependence, refer to practitioner resources on ICD-11 and DSM-5.
oMEDD is the total daily dose of any opioid(s) converted into an equivalent dose of oral morphine. There are calculators available that may be used to calculate theoMEDD, such as Faculty of Pain Management (FPM) ANZCA opioid calculator.
NSW Ministry of Health
Refer to Pharmaceutical Services website for supporting resources and detailed information.
Related legislation:
Drug Misuse and Trafficking Act 1985 (NSW)
Poisons Standard (SUSMP)
Disclaimer
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.
