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: derivatives of cannabis as defined in subsection 2(1) of the Cannabis Act that are exempt from the application of the Cannabis Act under the Industrial Hemp Regulations and that do not contain an isolated or concentrated phytocannabinoid or a synthetic duplicate of that phytocannabinoid, or anything referred to in Schedule 2 to the Cannabis Act that contains no more than 10 µg/g delta-9-tetrahydrocannabinol and that does not contain an isolated or concentrated phytocannabinoid or a synthetic duplicate of that phytocannabinoid. 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

E-mail: hc.hpfb_cannabis_dgpsa.sc@canada.ca