Agilient prepared a submission-ready Security Risk Management Plan that allowed a medicinal cannabis distributor to add a new third-party distribution facility to its licence without delay.
THE CHALLENGE
An Australian medicinal cannabis company distributes therapeutic goods through licensed third-party partners rather than operating its own warehouse. To add a new distribution facility to its licence, the company was required by its state health regulator to submit a site-specific Security Risk Management Plan. The plan had to describe how the company’s own stock would be received, stored and dispatched within a facility shared with other operators, and it had to satisfy both the state regulator and the Office of Drug Control. Because the products included Schedule 8 medicines, the documentation needed to be precise. Any gaps or requests for further information would delay the licence amendment and hold up the new supply channel.
OUR APPROACH
Agilient had prepared the original security plan for the partner facility, so the team began with a sound understanding of the site’s physical and procedural controls. That allowed the work to focus on what was specific to the client rather than re-establishing the baseline. Consultants reviewed the client’s product handling, storage and movement requirements within the shared facility and completed a targeted threat and vulnerability assessment. Controls were mapped against AS ISO 31000:2018 and the Australian Code of Good Wholesaling Practice for Medicines, and the plan was aligned with the state standard for the security of medicinal cannabis stock. Agilient worked directly with the client’s Qualified Person to confirm operational details and regulatory interpretations, so that the plan reflected how the product would actually be handled on site.
THE OUTCOME
The client received a regulator-ready plan that addressed the requirements for its licence amendment.
- A site-specific Security Risk Management Plan covering the client’s operations within the shared distribution facility
- Threat and vulnerability findings mapped to existing facility controls and to wholesaling and medicinal cannabis security requirements
- Delivery in under two weeks, supporting the onboarding of the new distribution partner
Related services: security risk assessment consultants, medicinal cannabis security compliance, pharmaceutical security. To discuss a similar project, contact Agilient.