Australia & Canada — Health Canada

Australia: Australia is a key international market where MedMira is initiating regulatory approval for its Canada — Health Canada-approved products under a Mutual Recognition Agreement, aiming to accelerate market entry and expand its international presence.

Canada — Health Canada: Canada — Health Canada is the regulatory body providing initial feedback to MedMira regarding the approval process for its Multiplo Complete Syphilis Antibody Test.

Australia: Australia is mentioned as a peer jurisdiction that has created a regulated framework for prescribing psilocybin and MDMA, serving as a comparative example for Canada.

Canada — Health Canada: Canada — Health Canada is the government agency responsible for drug approval processes in Canada. Bill C-286 seeks to streamline its Special Access Program for psilocybin and psilocin, which has been criticized for slow and unpredictable approvals.

Australia: Australia is currently a commercial market where Optimi Health's 5mg psilocybin capsules are prescribed to patients for treatment-resistant depression, demonstrating an existing successful market for the company's products.

Canada — Health Canada: Canada — Health Canada issued the Drug Establishment Licence (DEL) to Optimi Health, authorizing the company's manufacturing, packaging, labeling, testing, storage, and distribution of controlled drug products.

Australia: Australia is the recipient country for Optimi Health's psilocybin capsules, providing a regulated market for the treatment of treatment-resistant depression and setting a model for psychedelic medicine use.

Canada — Health Canada: Canada — Health Canada issued the Drug Establishment Licence for Optimi Health's facility and the export authorization for the psilocybin shipment to Australia, regulating the production and export of these controlled substances.

Australia: Australia is a market where Optimi Health Corp.'s 5mg psilocybin formulation is already commercially prescribed for treatment-resistant depression under the country's Authorized Prescriber Scheme.

Canada — Health Canada: Canada — Health Canada has issued a Drug Establishment License (DEL) to Optimi Health Corp., allowing it to produce and distribute regulated psychedelic drug products.

Australia: Australia previously approved WYNZORA, but is not directly affected by the Canadian launch.

Canada — Health Canada: Canada — Health Canada approved WYNZORA in December 2025, a regulatory prerequisite for the launch.