DMT and clinical trial authorities

​​​​On this ​page

1. Definitions​
2. Types of authorities
   
3. DMT authority
4. Clinical trial authority​
5. How to apply for an authority 
6. Fees and schedule of payments
7. Application processing times
8. When an authority is not required​​
9. More information 
   

​​​Definitions​​

• A ‘prohibited scheduled substance’ includes:
• Schedule 4D and Schedule 8 medicines
  
• Schedule 9 substances that are not defined as prohibited drugs in the Drug Misuse and Trafficking Act 1985 (DMTA).
• ​A prohibited drug is a substance listed in Schedule 1 of the DMTA​​, or an analogue of the listed substance.
• A prohibited plant is as defined under the DMTA​

It is an offence to manufacture, produce, possess, or supply prohibited scheduled substances, prohibited drugs, and prohibited plants without the appropriate authority.

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​​​​​Types of authorities

An authority under the Medicines, Poisons and Therapeutic Goods Act 2022​​is required to lawfully undertake activities with a prohibited scheduled substance, a prohibited drug or a prohibited plant.

The following authorities may be issued:

• ​DMT authority
  
• Clinical trial authority​
  

​DMT authority

​​A DMT authority allows an individual, or a class of persons within a facility, to lawfully: 

• possess, manufacture, supply, or administer prohibited drugs, prohibited scheduled substances, or prohibited plants, or
• cultivate prohibited plants

A DMT authority may only be issued for the purposes of medical or scientific research, analysis, teaching, or training.

Applicants are expected to ​have policies and procedures in place to ensure compliance with the legislation. These must address secure storage requirements and measures to reduce the risk of diversion.

DMT authorities issued to a class of persons will be published on the Orders and exemptions webpage.

Duration of a DMT authority

A DMT authority is valid for a term of 3 years, unless a different term is specified on the authority. The authority remains in force until it expires or is revoked or cancelled.

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​Clinical trial authority

• A clinical trial authority is required to prescribe, supply, or administer a Schedule 9 or Schedule 10 substance for use in a clinical trial.​
• A clinical trial authority is not required to conduct a trial involving a Schedule 2, 3, 4, 8 medicine, provided the medicines are prescribed, supplied or administered by an authorised practitioner.

Information on medicine and chemical scheduling is available in the Poisons Standard​​​​.

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​​​How to apply for an authority​

Applications for authorities will be available in late 2026.

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​Fees and schedule of payments

• ​Fees do not apply to clinical trial authorities

• Fees apply to the following DMT authority requests:

• new DMT authority applications
• amendments to a DMT application
• variations of an existing DMT authority.
• All applications must be accompanied by evidence of fee payment. Fee waivers may be granted to some charitable or not for profit organisations with appropriate supporting evidence.
  

How to pay​ ​​

Fees are paid online at the NSW Health Payment Platform. When making a payment you will need to select:

• ​hospital/facility: as relevant​
• health organisation: ‘Ministry of Health’ ​
• service: ‘Application/Licence Fee’​
  

Fees are non-refundable.​

DMT authority fees

Amendments and variations

• Changes made to an application while it is being assessed, and before approval are treated as an amendment and attract a fee equal to 50% of the application fee.
• Changes to an existing authority (such as changes to conditions, premises details, or business name) must be notified to Pharmaceutical Services. These changes are treated as a variation and attract a fee equal to 50% of the application fee.

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​Application processing times 

​Applications may take up to 90 days to assess from the date a completed application, including all required documentation, is received.

If the requested information is not provided within 6 months of the last communication from the NSW Ministry of Health, the application will be cancelled.

Providing false or misleading information is an offence under the Crimes Act 1900​​​​​.

Applicants will be notified of the outcome by email. If an authority is refused, reasons for the decision and any available review options will be provided.​

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​​When an authority is ​not required 

An authority is not required for universities, research and development laboratories, to obtain:

• a Schedule 2, 3, 4 (other than a Schedule 4D), or
  
• a 7J(a) substance

An authority is also not required by the above organisations for ​a prohibited schedule substance or prohibited drug where the substance is:

• an in vitro diagnostic or analytical preparation, and
• it contains less than 0.001% of the prohibited substance or drug.​