Notice of Amendment: Prescription Drug List (PDL): Phytocannabinoids

Date: October 17, 2018

Our file number: 18-114531-372

The purpose of this Notice of Amendment is to notify that Health Canada has added phytocannabinoids to the Human and Veterinary Prescription Drug Lists (PDL). These additions are effective immediately.

The following classification parameters will immediately apply to health products containing cannabis: Any product making a health claim that contains a phytocannabinoid produced by or found in the cannabis plant, but not including health products containing parts of the cannabis plant that fall outside the legal definition of cannabis or that are exempted from the Cannabis Act (i.e., permitted cannabis parts which contain ≤ 10 ppm of THC and no other phytocannabinoids), will be classified as a prescription drug. All phytocannabinoids have been pre-emptively added to the PDL, with the exception of the latter exemption. 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:
  1. 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
  2. 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
2018-10-17

Rationale:

Clinical evidence supporting the safety and efficacy of cannabis and its constituents for therapeutic purposes is currently insufficient to set acceptable threshold dosages 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 which naturally exist within cannabis. The cannabis-based drug products which have been authorized by Health Canada under the former legislative framework have been studied, authorized and used in specific conditions on a limited subset of the population. 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.

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 Prescription Drug List 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

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