Notice of intent to amend: Prescription Drug List (PDL): Phytocannabinoids
July 11, 2018
Our file number: 18-107455-965
The purpose of this Notice of Intent to Amend is to announce that Health Canada will add phytocannabinoids to the Human and Veterinary Prescription Drug Lists (PDL). This addition will be effective upon the coming into force of the Cannabis Act.
The listing will read:
| Drugs containing any of the following: | Including (but not limited to) | Qualifier | Effective Date (yyyy-mm-dd) |
| Phytocannabinoids produced by, or found in, the cannabis plant and substances that are duplicates of such phytocannabinoids. | except:
|
Upon the coming into force of the Cannabis Act and Regulations. |
Rationale:
Clinical evidence supporting the safety and efficacy of cannabis and its constituents for therapeutic purposes is currently insufficient to set acceptable dosage or other thresholds for non-prescription use. While Health Canada has previously authorized health products containing cannabis, there remains significant scientific uncertainty regarding the pharmacological actions, therapeutic effectiveness and safety of the majority of phytocannabinoids. The cannabis-based drug products which have been authorized by Health Canada have been studied, authorized and used in specific conditions. While these authorized products have contributed to the global body of knowledge concerning the safety and efficacy of cannabis-based therapies, the presence of scientific uncertainty and limited market experience gives rise to the need for a precautionary approach. Listing all phytocannabinoids on the PDL addresses this uncertainty by allowing healthcare practitioners to monitor and manage any unanticipated effects.
When added, all phytocannabinoids will remain listed on the PDL until there is sufficient scientific evidence (e.g., as demonstrated through a submission to Health Canada) to change the prescription status of a particular phytocannabinoid when used in specific conditions. Pursuant to section C.01.040.3 of the Food and Drug Regulations, Health Canada considers several criteria when deciding whether a health product would be required to be sold as a prescription drug. Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.
Should you have any questions on this amendment to the PDL please contact:
Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9
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