Health Canada just published a notice of intent —
Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues

http://www.gazette.gc.ca/rp-pr/p1/2020/2020-12-12/html/notice-avis-eng.html#nb1

PART 1: Proposed regulations amending the Cannabis Regulations and associated regulations to facilitate non-therapeutic cannabis research involving human participants and cannabis testing

PART 2: Feedback on additional regulatory issues:
- Public possession limit
- Product labelling
- Micro class and nursery licences
- COVID-19 measures

The notice initiates a 30-day comment period. HC is seeking feedback/comments to ensure that the proposed amendments with respect to cannabis research and testing are informed by and responsive to the cannabis industry, researchers, other relevant stakeholders and the public.

1. How likely would you conduct non-therapeutic cannabis research involving human participants? How many studies do you envision conducting in a year?

2. Should the requirements to conduct non-therapeutic cannabis research involving human participants under the CR be similar to those that currently apply to clinical trials under the FDR (e.g. protocol review by a research ethics board, submission of extensive quality ...

... [chemistry and manufacturing] information, review of written informed consent, and submission of an investigator’s brochure)? If the requirements should differ, how?

3. Should non-therapeutic research involving human participants be restricted to certain participants (e.g. exclude individuals with previous/current mental health or substance use disorders, age restrictions)?

4. Should there be restrictions on the types of cannabis used in non-therapeutic cannabis research involving human participants? If so, under what circumstances? What should the quality requirements be for cannabis derived from synthetic sources?

5. Should there be restrictions on the dosage, frequency, duration and route of administration (e.g. smoking or vaping) of cannabis used in non-therapeutic cannabis research involving human participants?

6. Should adverse reaction reporting for non-therapeutic cannabis research involving human participants be treated in a similar manner as adverse reaction reporting for clinical trials under the FDR? Why or why not?

7. What are your thoughts on expanding the production, distribution and sale activities of cannabis reference standards and test kits? What are the potential risks and benefits of this approach (e.g. by exempting reference standards from GPP requirements)?

8. Are there any impediments stemming from the current requirements for the “head of laboratory” under the CR?

9. Do you think the public possession statement on cannabis product labels helps adults comply with the public possession limit?

10. Currently, the CR require labels to display a statement to express the amount of cannabis a product is equivalent to in terms of grams of dried cannabis. Do you see any issues with this approach? Are there any benefits or challenges you think an adult may have in ...

... interpreting this information on different kinds of cannabis products (e.g. edible cannabis, cannabis topicals, vaping products, etc.)?

11. Do you think the current public possession limit for cannabis beverages (which is currently approximately 2 litres) should be increased? If yes, please explain what you think an appropriate public possession limit would be for these products and why.

12. Should Health Canada require product labels to display information about other cannabinoids and terpenes (e.g. quantity or concentration)? Why or why not? If yes, which cannabinoids and terpenes and why?

13. Is there any other labelling information that would help consumers make decisions to support informed and responsible use?

14. Are the regulatory requirements for the micro-cultivation, micro-processing and nursery licences (e.g. cultivation and processing limits) appropriate given their scale?

15. Are there any elements of the regulatory framework that put micro-cultivation, micro-processing and nursery licence holders at a competitive disadvantage compared to larger companies? If so, how, and what adjustments would you propose?

16. Are there any [covid-19] measures that should be made permanent? What would be the impact if these measures were not continued? Are there any risks of making a measure permanent and how should they be mitigated?

Again, the 30 day window for comments has started. Any inquiries/comments for this NOI must be sent to [email protected] stating "Notice of intent —Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues" in the subject line.

End.