A “medicinal cannabis product” is defined in section 4 of the Narcotic Drugs Act 1967 (Cth) (“ND Act”) to mean “a product, including but not limited to a substance, composition, preparation or mixture, that:
(a)
includes, or is from, any part of the cannabis plant; and
(b)
is for use for the purposes of curing, or alleviating the symptoms of, a disease, ailment or injury.”
The import and manufacture of medicinal cannabis products are subject to regulation by the Office of Drug Control (“ODC”) of the Australian Commonwealth Department of Health.
In order to import medicinal cannabis products (which are not Approved Products) into Australia, pursuant to regulation 5 of the Customs (Prohibited Imports) Regulations 1956 (Cth), the importer must hold:
(a)
a licence to import drugs (“Import Licence”); and
(b)
a permission to import each consignment of each specific drug (“Australian Import Permit”),
and must comply with any conditions of the Import Licence and Australian Import Permit.
Import Licences are applied for by the proposed importer in writing from the Secretary of the Australian Commonwealth Department of Health (“Secretary”). The application must be in the approved form. Import Licences are issued for a 12 month period.
In order to be granted an Import Licence, the applicant must provide all requested information to the Secretary, demonstrate that it, and its agents and employees, are fit and proper persons to be granted the Import Licence, and demonstrate that its drug storage facilities meet the security requirements for that purpose.
Once an Import Licence is granted, the Import Licence holder must comply with certain requirements, including:
(a)
keeping any drug that is in the possession of the Import Licence holder in safe custody at all times, and if the drug is moved from one place to another, taking adequate precautions to ensure that the removal is safely carried out;
(b)
taking reasonable precautions to ensure that there is no danger of loss or theft of any drug in the possession of the Licence holder;
(c)
only supplying medicinal cannabis products if the Import Licence holder is satisfied that the product will be used solely for medical or scientific purposes; and
(d)
keeping records including about the name and quantity of each drug in the possession of the Import Licence holder, and the quantity of each drug supplied by the Import Licence holder, and information about the person to whom the drug was supplied.
The Import Licence may be revoked if the Import Licence holder does not comply with these requirements.
An application for each Australian Import Permit must be made in writing to the Secretary by the proposed importer. The application must be in the approved form. An Australian Import Permit will not be granted unless the applicant has provided all requested information to the Secretary, has made proper arrangements for the safe transportation and custody of the products, and
(a)
if the product is required for the manufacture of a drug at certain premises —
(i)
the applicant is a holder of a manufacturer’s licence in relation to the manufacture of the drug at those premises pursuant to requirements of the ND Act, which is administered by the ODC (“ND Manufacturer’s Licence”); and
(ii)
where the manufacture of the drug is prohibited under a law of the Australian state (“State”) or territory (“Territory”) in which those premises are situated unless a licence to manufacture the drug has been granted under that law, for the purposes of that law, the applicant is the holder of