Section C.08.010(1) of the Food and Drug Regulations lets the Minister issue a letter of authorization to a manufacturer of a new drug, authorizing the sale of a specified quantity to a practitioner for the emergency treatment of a patient, once the practitioner supplies details such as the medical emergency and the quantity needed (Justice Laws, FDR).
Health Canada says that when a psilocybin request through the Special Access Program is authorized, the manufacturer is issued a Letter of Authorization permitting it to legally sell the specified quantity. Because psilocybin is controlled, the product must also be imported by a licensed dealer with psilocybin on its licence (Health Canada, magic mushrooms). Its Special Access page notes that the letter goes to the manufacturer with a copy to the practitioner (Health Canada, SAP drugs).
The letter is tied to one patient and one quantity. It is not a marketing approval, and Health Canada says there are no approved therapeutic products containing psilocybin. Not legal or medical advice.
General information, not legal advice.
Sources
- Justice Laws: Food and Drug Regulations (C.08.010)
- Health Canada: Magic mushrooms
- Health Canada: Special Access Program for drugs
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