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Purpose
This guidance helps medicinal cannabis licence holders understand the requirements for testing cannabis, cannabis resin and cannabis-derived products in Australia. It also explains when testing services can be provided by external organisations.
Testing medicinal cannabis
Testing may be required to support:
- product development
- quality assurance
- compliance with quality specifications
- cannabinoid content analysis
- research activities.
Not all licence holders have in-house testing capabilities, so external laboratories or testing providers may be used where appropriate.
Using third-party testing providers
Licence holders may provide medicinal cannabis materials to third-party service providers for testing, subject to the conditions of their licence and regulatory requirements.
When using a testing provider, licence holders must ensure the provider:
- holds any required state or territory licences to handle controlled substances
- is authorised to handle cannabis materials relevant to the service being provided
- uses the material only for the agreed testing purposes.
Record-keeping requirements
Licence holders must keep records of:
- cannabis materials provided for testing
- any material returned by the service provider
- agreements, contracts or service records relating to the testing services provided.
Documentation should clearly identify:
- the amount of cannabis or cannabis-derived material supplied
- the testing services performed
- the outcome or disposal of unused material.
Unused material
Unused medicinal cannabis material must be:
- returned to the licence holder
- retained by the service provider for approved reference or method development purposes, where permitted
- destroyed in accordance with relevant state or territory requirements.
Research activities
Licence holders undertaking research may use external providers to conduct testing they cannot perform themselves. However, the research activities authorised under a licence cannot be entirely outsourced to another organisation.
Where an organisation is undertaking activities beyond testing, such as manufacturing medicinal cannabis products on behalf of a licence holder, additional licensing requirements may apply.
Requirements for service providers
A service provider does not generally need a licence under the Narcotic Drugs Act 1967 if:
- the testing is performed solely for the licence holder
- ownership of the cannabis material remains with the licence holder
- the material is not supplied to another person
- the provider is only conducting testing services and not undertaking research or manufacturing activities on behalf of the licence holder.
Service providers that do not meet these conditions, or that intend to extract material from cannabis plant material, cannabis resin or cannabis oils, should contact the Office of Drug Control to discuss licensing requirements.
More information
For additional information about medicinal cannabis licensing, testing and compliance requirements, visit the Office of Drug Control website.