Halucenex Life Sciences, a wholly-owned psychedelics subsidiary of Creso Pharma, announced it has been awarded a Controlled Drugs and Substances Dealer’s Licence from Health Canada
As one of the few companies worldwide with a Dealer’s Licence, Halucenex is now able to possess, sell, transport and conduct R&D on a range of psychedelics, such as psilocybin, ketamine, LSD and MDMA
Creso Pharma (ASX: CPH) (OTC: COPHF) (FRA: 1X8) announced that, on August 11, 2021, its wholly-owned Canadian psychedelics subsidiary, Halucenex Life Sciences secured the highly sought-after Controlled Drugs and Substances Dealer’s Licence from Health Canada.
This news is a milestone achievement for Halucenex as the psychedelics firm can now move forward with its planned phase II clinical trial, which will seek to test the efficacy of psilocybin on treatment-resistant post-traumatic stress disorder (PTSD).
A company in possession of a Health Canada Controlled Drugs and Substances Dealer’s Licence is, as specified on the license, able to poses certain controlled substances to conduct specific activities, which include:
- Clinical studies
- Research & development
- Laboratory analysis
- Production & sales
- Import & export
As it relates to Halucenex, the company’s newly obtained Dealer’s Licence permits the firm to possess, sell, provide, transport, deliver and conduct R&D on psychedelic substances including psilocybin, ketamine, LSD, MDMA, Salvia divinorum, harmaline, salvinorin A, as well as additional Approved Controlled Substances.
As previously reported, Halucenex intends to immediately seek an amendment to its Health Canada Dealer’s Licence to allow the company to produce, package, and assemble the Approved Controlled Substances.
“The receipt of our Dealer’s Licence is the result of a stringent due diligence process undertaken by Health Canada, as well as ongoing consultations with the regulatory body which have highlighted the exceptional standards of our operations and R&D protocol. To date, we have been focused on the lead-up to this milestone and have done a lot of essential preparatory work in anticipation of receipt of the Dealer’s Licence, which will provide us with a significant competitive advantage as we progress our entry into the lucrative psychedelics drug space. We are now very well placed to deliver on a number of value accretive initiatives, which have the potential to unlock significant value for shareholders and further cement our standing as a leader in emerging psychedelic inspired therapies,” commented Bill Fleming, Founder & CEO of Halucenex.
Bruce Linton, the future Chairman of The HighBrid Lab, the combined company resulting from the pending Creso Pharma (ASX: CPH) (OTC: COPHF) (FRA: 1X8) x Red Light Holland (CSE: TRIP) (OTC: TRUFF) (FRA: 4YX) merger, issued the following statement in response to Halucenex securing the Dealer’s Licence:
“We are very eager to begin working with Halucenex ahead of the creation of The HighBrid Lab and explore opportunities which will increase the uptake and availability of psychedelics as an evolutionary treatment route to existing therapies. As the mental health crisis continues to unfold, the need for effective treatments is becoming much clearer. The potential and requirements for new treatment pathways is also becoming widely recognised by regulatory bodies, governments and large pharmaceutical companies – all of which provide us with a number of avenues as we embark on test work, R&D and commercialisation.”
The Halucenex Dealer’s Licence is valid until August 31, 2022, and is subject to the standard Health Canada licence renewal process. Under the Dealer’s Licence, Halucenex may sell or provide the Approved Controlled Substances in the following circumstances:
- In the case of substances covered by the Canadian Food and Drug Regulations(including Salvia divinorum and salvinorin A, GHB, harmaline, LSD, DMT and MDMA), sales are restricted to research/clinical institutions (including other licensed dealers), the Minister, medical practitioners (with the proper exemptions) for identification or analysis; and
- In the case of narcotics covered by the Canadian Narcotic Control Regulations (including ketamine and phencyclidine), sales are restricted to other licensed dealers, pharmacists, medical practitioners, hospital employees, section 56 exemption holders, and the Minister.
- In the case of psilocybin, the Dealer’s Licence allows Halucenex to sell or provide psilocybin to other licensed dealers and, upon pre-approval by Health Canada, to Part J (of the Food and Drug Regulations) authorization holders for clinical testing or laboratory research only.
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