Health Canada has proposed a regulatory pathway for a new class of cannabis products known as Cannabis Health Products (CHPs). On June 19, 2019, Health Canada started a consultation on potential market for CHPs that would not require a practitioner’s oversight. Health Canada are accepting comments until September 3, 2019. There is currently a growing interest in potential therapeutic use of cannabis for minor ailments. In addition, cannabis products with unauthorized health claims are emerging on the market illegally such as cannabidiol (CBD) products. Natural health products and cosmetics are currently being marketed containing no more than 10 parts per million (ppm) tetrahydrocannabinol (THC). This is outside the scope of this proposal and current oversight of these products would not be affected, for example hemp products.
The current regulatory framework for Cannabis in Canada:
In the current regulatory context, there is no legal way to sell a CHP without the oversight of a practitioner such as a Doctor or Veterinarian.
Since October 2018, the following two categories of products were permitted:
- Cannabis products for non-medical and medical purposes; and
- Prescription drugs containing Cannabis.
Cannabis products, whether sold for medicinal or non-medicinal purposes, cannot be sold with labels or marketed in a manner that provides information about health benefits, appropriate dosing, or other information about their use as a treatment for health conditions.
The proposed new regulatory approach for CHPs:
Prescription drugs that contain cannabis are subject to a scientific review by Health Canada for safety, efficacy and quality before they can be sold, and are marketed with authorized health claims.
HC proposes to allow CHPs to include any cannabis ingredient or substances extracted from cannabis, as well as other medicinal and non-medicinal ingredients supported by robust scientific evidence. Robust scientific evidence would also be required to demonstrate that the interaction of the different substances would be safe and effective. Therefore, Health Canada asks in the current survey if and what “scientific evidence” is currently available that demonstrates the efficacy of cannabis and / or if industries are working on generating any evidence?
However, it remains unclear what will be accepted by Health Canada for “scientific evidence” (e.g. published scientific literature? Clinical trial data? Data from non-interventional studies?).
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Source: https://www.gmp-compliance.org/gmp-news/canadas-new-regulatory-approach-for-cannabis-products
