From October 2016, the Australian Office of Drug Control (ODC) began processing license applications for the cultivation, production and manufacturing of medicinal cannabis, or medical cannabis as per the Narcotic Drugs Amendment Act 2016 (NDAA). Australia has a well established opioid industry and the regulators are rightfully careful to control access to medical cannabis for medical use only.
Licences needed to cultivate and produce medicinal cannabis
Generally, medicinal cannabis cultivation in Australia requires a single licence from the ODC which will allow an organisation to cultivate and produce the plant. However, this requirement changes if a grower is using an external party during any part of the process, for example, utilising external contractors to collect seeds. The contractor will then also need their own cannabis production license and permit, making it unlikely that growers will outsource part of their cultivation process.
ODC Security Consultants
PharmOut works with a number of ODC security consultants however we prefer to work closely with preferred partner experienced in medicinal products for traditional scheduled drugs and Goods with High Illicit Value.
Licences needed to process medicinal cannabis
Companies undertaking downstream processing, i.e. the extraction, purification etc of cannabis will need a manufacturing licence from the Australian Office of Drug Control (and the mostly likely TGA) as well as a poisons license from the appropriate state or territory. Classified as a schedule 8 drug, the appropriate security systems must be in place for medicinal cannabis manufacturing on the site. Typically, schedule 8 drug manufacturers apply the ISO 31000:2009 Risk Management standard when assessing and implementing appropriate security.
Federal or State regulation?
There are two crude tests to determine if a drug is regulated by the Australian Federal Government or a State government.
- If the drug crosses state boundaries or they are made for stock then the drug is regulated at Federal level by the Therapeutic Goods Administration (TGA).
- If the drug is manufactured within a state and does not leave that state then it is regulated by the State. Each state has different laws. A typical scenario here is a pharmacist processing a drug for a named patient. Note that there are strict criteria controlling this activity.
It is unlikely that cannabinoids from cannabis plants can be economically extracted on a patient-by-patient basis, with simple scales of economies precluding this micro scale manufacturing. The more likely scenario is that all downstream manufacturing of medicinal cannabis will take place in a manufacturing plant that has a TGA manufacturing license for the manufacture of an Active Pharmaceutical Ingredient (API). Pharmacies could receive the bulk material from the manufacturer and dispense for a single named patient through the Special Access Scheme (SAS), clinical trial, or as an Authorised Prescriber.
ODC License for Cultivation and production of medicinal cannabis
TGA Medicinal Cannabis Manufacturing Licenses – Active Pharmaceutical Ingredient (API)
TGA Medicinal Cannabis Manufacturing Licenses – Final Dosage Forms (FDF)