Although psilocybin is illegal in Canada, the dealer’s license authorizes sale under Health Canada’s Special Access Program.
Health Canada has approved Apex Labs’ Controlled Drugs and Substances dealer’s license, the company said.
The dealer’s license “authorizes Apex to sell psilocybin, including APEX-52 microdose and APEX-90 macrodose psilocybin drug products developed in collaboration with licensed dealers in Canada and the United States,” Apex Labs explained in a news release.
Although psilocybin is illegal in Canada, the dealer’s license authorizes sale under Health Canada’s Special Access Program (SAP).
APEX’s psilocybin products previously have been used to dose veteran patients both in clinical trials and through the SAP, according to the company.
“Receiving this license is a significant achievement for APEX alongside our tremendous progress actively dosing patients through our early-access program and gearing up to launch multiple clinical trials,” said Tyler Powell, co-founder and CEO. “We are grateful to Health Canada for processing APEX’s license application so quickly, signaling the importance of access to controlled and regulated psilocybin.”
The dealer’s license “simplifies the supply chain and broadens communication for APEX’s psilocybin products by allowing direct sales for the SAP or investigator-led clinical trials,” the company added.
“APEX worked with Health Canada to issue this dealer’s license less than four months from application with no observations,” said Dr. David Wood, principal of R-Group Legal, regulatory counsel and strategic advisor to APEX since 2020. “Health Canada’s responsiveness and clarity made for a simple and straightforward process.”