In January 2018 the federal health minister announced that, after industry consultation, the export of Medicinal Cannabis from Australia would now be permitted.
Subsequently, the export of Medicinal Cannabis products was legalised in February 2018 through the Narcotic Drugs Amendment (Cannabis) Regulations 2018. The ODC Export of Medicinal Cannabis, Guidance for Cultivators and Manufacturers of Medicinal Cannabis was released in April.
The export announcement and the roll out of regulations resulted in a noticeable surge in interest of local cultivators, manufactures and investors as business options have become more diversified.
1. Will the ability to export have any impact on local supply?
The primary concern arising from the push into the export of Medicinal Cannabis is that there will be a lack of local supply to Australian patients.
Currently, this is unlikely for a number reasons including:
1. The small patient population in Australia.
2. The slow progress in the establishment of GMP manufacturing and doctor prescribing, i.e. the small legal demand for Medicinal Cannabis.
3. The number Medicinal Cannabis cultivators and manufacturers already licenced and their large untapped capacities.
However, because Australia is regulating Medicinal Cannabis as if it were any other medicine on the market (mostly), the knowledge that these products are produced to high quality standards could result in an increased demand for Australian products on the international market.
Thus, to alleviate this concern, the ODC has stipulated that the exporting party must give assurance that the local supply will not be impacted and will be “tested as part of ongoing compliance and monitoring program”.
2. The three prerequisites for the export of Medicinal Cannabis products:
“So why can’t I just grow a crop, throw it in a container and send it off overseas?”
The first criteria to fulfil when exporting Finished Products (be they oils, tinctures, capsules, tablets or flower*) is that they must be made in compliance with Good Manufacturing Practices, the same standards used to manufacture all medicinal products.
According to regulations, “raw” cannabis biomass (flower* or leaves) or resin (hash) cannot be exported at all: only cannabis extracts manufactured under an ODC manufacturing licence or finished products manufactured under a TGA licence can be exported.
The second criteria to fulfil, is that Medicinal Cannabis products must be listed or registered on the Australian Register of Therapeutic Goods (ARTG) under the name of the product sponsor. The sponsor must be an Australian resident or carrying on business in Australia, but may also have agents acting on their behalf.
Registration of medicines on the ARTG is the “classical” pathway for medicines in the Australian market where the data has been gathered by the manufacturer/sponsor by going through the full drug development journey, from toxicology and animal studies to Phase I-III clinical trials over several years.
Normally, a listed medicine will contain an active ingredient which is pre-approved by the TGA. However, ingredients which are scheduled poisons are not approved and therefore products containing them cannot be listed on the ARTG.
However, Medicinal Cannabis products that come under the Schedule 4 (>98% cannabinoid) or Schedule 8 (>2% other cannabinoids) poisons classification may qualify for an export-only listing.
For an export only listing, the product cannot be supplied locally, and the product must be separate and distinct from any locally supplied product in at least one of the following ways:
• Different formulation
• Different strength
• Different dosage form
• Different name
• Different indications
• Different directions for use
• Different container
The third criteria to fulfil is to obtain an export licence from the Office of Drug Control (ODC) under the Customs (Prohibited Exports) Regulations 1958.
An export licence will only be granted if the cultivation/production/manufacture licence allows export and the exporter has the required state/territory government wholesale licence. In the case of the state/territory possession and wholesale licences it would be expected this would already be in place if the exporter was actively cultivating and manufacturing.
For manufacturers who already have an ODC licence but now want to export they must apply for a variation to their licence through the ODC. A variation fee is payable.
Once the export licence has been obtained, the exporter will need a permit from the ODC for every export of Medicinal Cannabis consignment planned.
An important caveat to bear in mind is that export permission will not be given if the importing sovereign state does not allow these imports in the first place!
3. How we can help:
If you are confused by all the information presented but are interested in the manufacture of export of Medicinal Cannabis, PharmOut have a proven track record in helping Medicinal Cannabis manufacturers in obtaining ODC, TGA and export licenses. Contact us here for an obligation-free chat.
*Note: “Flower” appears both as permitted and prohibited in the above blog. The distinction is that only flower manufactured under Annex 7 of the GMP code as a herbal medicine would be approved for export.
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