Regulatory Environment

PsiloTec is in the process of applying for a

Controlled Drugs and Substances License.

The estimated timeline for approval is Q4, 2021.


The Controlled Drugs and Substances Act (CDSA) currently lists psilocybin as a Schedule III narcotic. To legally produce or distribute, a dealer’s license must be granted.


In August, 2020, Canada Health began giving exemptions on an individual basis to the

CDSA for individuals to utilize psilocybin both for anxiety in palliative care and for

other mental health conditions.  To date, 13 individuals have been given

access for palliative care; 1 for PTSD.

The Canadian Federal Minister of Health is currently considering allowing

healthcare professionals and clinicians section 56 exemptions for clinical use.

A decision is expected before the end of 2021.

In November, 2020, Vancouver city council unanimously backed a motion

seeking to decriminalize possession, including psilocybin.


In November, 2020, Oregon passed measure 109, legalizing psilocybin for medicinal use.

The state has two years to create a framework. Washington DC, Oakland,

Santa Cruz, Ann Arbor and Denver are among the US cities

which have already decriminalized psilocybin.

Other countries with legalization or decriminalized psilocybin for personal use include:

Austria, Bahamas, Brazil, Jamaica, Nepal, Netherlands, Samoa, Spain and Uruguay.

PsiloTec plans on being able to supply the rapidly increasing legal market in 2022.