The TGA recently held a webinar called ‘Meeting Your Obligations – Supplying medicinal cannabis in Australia,’ and while it was useful as an overview of the therapeutic good development lifecycle, it did not delve too much into the main supply pathways that are actively being used for unapproved medicinal cannabis products.
Considering the new Schedule 3 (S3) CBD classification, it is understandable why the TGA is encouraging the cannabis industry to proceed via the traditional product registration routes. S3 CBD was briefly touched on during the webinar, and if you wish to read more on S3 CBD, its implications, and how to register an N5 application, please refer to this previous blog.
Given that there are already pathways for accessing unapproved therapeutic goods in Australia, and the fact that these pathways are popular in the cannabis industry, I felt it would be useful to point out some major caveats regarding supply (or one major caveat in particular).
Limitations around unapproved medicines
Most cannabis products in circulation are not included in the Australian Register of Therapeutic Goods (ARTG) and are therefore considered “unapproved medicines.”
Health professionals can access unapproved medicines via the Special Access Scheme (SAS) and Authorised Prescriber (AP) routes through online registration systems and their relevant State/Territory Health Department.
Before supplying an unapproved medicinal cannabis product, manufacturers and suppliers (also known as “sponsors”), should be aware that there are additional restrictions in place around advertising as well as supply.
Bottom line? You are NOT allowed to wholesale unapproved medicinal cannabis products – this includes selling to wholesalers themselves, even if they are licenced to wholesale by their state or territory.
A little known, but crucial guidance document provides a very clear summary and I would advise all those who participate in the supply chain to review it carefully: Supply and wholesaling of medicinal cannabis products (MCP)
A summary of direct control requirements
Unapproved medicinal cannabis products must be in DIRECT control of the sponsor, meaning:
- Products remain under the sponsor’s control until they are supplied under SAS B, AP, or the clinical trial exemptions.
- Products are kept in a warehouse or secured area which is known to the sponsor, and over which the sponsor has contractual and practical control.
- Products are only released for supply with approval from the sponsor (with any supply or movement of the goods being specifically notified to the sponsor, so that the sponsor maintains appropriate records).
Direct control can be a confusing concept, especially if third parties have been contracted to perform warehousing services, however the TGA does provide a useful clarification between:
- ‘Wholesale’ arrangements – where the goods are sold to a third party who intend to on-sell products.
- ‘Distribution’ arrangements – where a third party provides services to the sponsor (such as warehousing, courier and brokering services) in relation to the goods, but the sponsor always retains ownership of, and direct control over the goods before they are supplied.
In scenario 1, once you hand over the goods, you are not “direct” supplying through one of the approved pathways (AP/SAS/Clinical trials) and have no more control or knowledge of the fate of the products after that sale. In scenario 2, although you have technically handed over goods to a third party, you still maintain control over how the product is stored and the third party requires your approval prior to conducting any supply activities down one of the approved pathways.
How do I know if I’ve lost direct control?
If you have supplied your medicinal cannabis products to a third party (that is not an authorised medical practitioner, pharmacist, or a patient) and are unsure as to the level of control you currently hold, I have prepared a little quiz to help clarify your position below:
- Do you have an agreement in place regarding sponsor/service provider responsibilities that covers these direct control requirements?
- Do you have control or knowledge of how your medicinal cannabis goods are stored regarding security, environmental conditions, etc.?
- Do you have control or knowledge of the exact quantities of your medicinal cannabis goods that have been stored and supplied?
- Do you have control over when the medicinal cannabis goods are supplied, and to whom?
- Do you keep records relating to the source, storage, and supply of these medicinal cannabis goods?
If you answered “no” to any of these questions, then there is a chance that your supply of medicinal cannabis may be considered unlawful!
The Act states that:
“It is a criminal offence for a person who is not a sponsor of a therapeutic good to supply that therapeutic good to ‘another person who is not the ultimate consumer of the goods’ (including by wholesale) unless the goods are subject to a relevant exemption, approval or authority. In the case of medicinal cannabis products, this [exemption] will generally be SAS B, AP, CTN or CTA.”
Additionally, even after final lawful supply activities have occurred, sponsors’ responsibilities do not end there, and you are required to conduct ongoing monitoring of your products.
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