OCS – Psilocybin

Controlled Substances Applications including Psilocybin

OCS – Psilocybin

Office of Controlled Substances Applications including Psilocybin

Office of Controlled Substances Applications including Psilocybin

The terms “magic mushrooms” and “medical mushrooms” are interchangeable. Its language is used to refer to mushrooms that contain real, physiologically active substances (hallucinogens), such psilocybin and psilocin.

  • Psilocybin (chemical name: 3–[2–(dimethylamino)ethyl]–4–phosphoryloxyindole)
  • Psilocin (chemical name: 3–[2–(dimethylamino)ethyl]–4–hydroxyindole)

Due to the fact that psilocybin and psilocin are listed as Schedule III substances under the Controlled Drugs and Substances Act (CDSA), it is illegal to possess, sell, or produce them unless it is permitted by Part J of the Food and Drug Regulations.

Experts are currently studying Psilocybin for its potential to treat several conditions, such as:

  • Anxiety
  • Depression
  • Obsessive Compulsive Disorder
  • Problematic Drug Use

Please be aware that administration of the purified active ingredient in clinically monitored circumstances is required for studies involving the use of psilocybin. There are currently very few psilocybin-containing medicinal drugs that have been licenced in Canada.

TCSI offers consulting services for OCS Applications (including Psilocybin), Psilocybin R & D license, psilocybin clinical trials license and dealer’s license.

Types of OCS license application services that TCSI offers:

• Application for an exemption to use a controlled substance for clinical studies
• R & D Application for an exemption to use a controlled substance for scientific purposes
• Application for a Controlled Drugs and Substances Dealer’s Licence

License Requirements for Clinical Trials with Psilocybin

Clinical Trials with Psilocybin

Conducting clinical research is a critical step in the generation of good quality evidence needed to better understand the health benefits and harms associated with the potential therapeutic use of psilocybin. Clinical trials are the most appropriate and effective way to advance research with psilocybin while protecting the health and safety of patients and should be the first legal route pursued by individuals seeking access for therapeutic treatment.

Clinical trials protect patients by providing a framework so that a potential treatment is administered in accordance with national and international ethical, medical and scientific standards. They also must be approved by a research ethics board, which provides additional oversight to ensure that patients’ health and safety are protected.

Drugs used in clinical trials must meet Good Manufacturing Practices, the manufacturing standard used in the pharmaceutical industry, to ensure that patients are administered known quantities of quality-controlled active ingredients. This ensures that trial results are representative and reproducible. Clinical trials also benefit society because they help build the evidence related to the safety and efficacy of treatment options for patients.

Requirements For An Exemption To Use A Controlled Substance For Clinical Studies

A qualified investigator (QI) (practitioners affiliated to universities and/or private industry) requiring a controlled substance for research purposes which include administration to humans in a clinical trial must receive an exemption under subsection 56(1) of the Controlled Drugs and Substances Act (CDSA).Thus, once issued, an exemption will authorize the qualified investigator (practitioner) to purchase (if applicable), possess and administer specific controlled substances in specific quantities for a specific clinical study protocol.  Members of the research staff who are working on the same research project under the direction and control of the practitioner are also exempted within the same scope and for the same purpose as the practitioner.  Please note that you are responsible for any portion of the controlled substance that is administered by or in the possession of by these individuals.

Exemptions are valid for one year from the issuance date. You may apply for an extension if required.

Before an exemption can be issued, you must first submit a Clinical Trial Application (CTA) to the Office of Clinical Trials of the Therapeutic Products Directorate.  If they process the application favorably, a no objection letter (NOL) will be issued.

Then, you may apply for an exemption. With the completed application, a copy of the Protocol and the NOL must be provided.

Exemption To Use A Controlled Substance For Clinical Studies

Requirements for An Exemption to Use A Controlled Substance For Scientific Purposes

Clinical Trials with Psilocybin
Requirements for An Exemption to Use A Controlled Substance For Scientific Purposes

To apply, the application requires a Principal Investigator (PI) or person responsible for the project and should have a minimum of a bachelor’s degree in science (B.Sc.).

Exemptions can be issued for all substances listed in Schedules I-IV of the Controlled Drugs and Substances Act (CDSA).

Exemptions are protocol, principal investigator, site and substance specific. Therefore, the application must be submitted in the applicants name, which specifies the controlled substance(s) and protocol(s) to be used.  It should be noted that the exemption issued also extends to all colleagues, assistants and technicians participating in the same project to possess and use the controlled substance, as long as these individuals are under your direction and control. The applicant is responsible for any portion of controlled substance used by any one of these individuals.

Exemptions are valid for one year from the issuance date. You may apply for an extension if required.

Sufficient information must be supplied to Health Canada to support the use of a controlled substance in the project or protocol and to provide confirmation that the controlled substance will be stored in a secure manner.

Please note that the following documents may be required as part of your application:

Application form with signature (required);

  • A copy of the research protocol and/or amendments to the protocol (in vivo administration and in vitro utilisation); and
  • The current year’s approval of the protocol from the local Animal Care Committee (in vivo administration).
  • If the controlled substance for which you are seeking a scientific exemption is not available in Canada, the Office of Controlled Substances’ licensed dealership may import it from another country on your behalf. If this is the case, please complete the Import Order Authorization and Permit Application Form (IOPAF) and return it with your application.

Application for Controlled Drugs and Substances Dealer’s Licence

An application for Controlled Drugs and Substances Dealer’s Licence authorizes a company or organization to possess a controlled substance and conduct activities specified by the license (such as production, packaging, sale, sending, transportation, delivery, laboratory analysis, research & development, clinical studies, import/export, or distribution under special access program only). A Dealer’s License will only be issued once a complete license application package has been reviewed by Health Canada’s Office of Controlled Substances (OCS), and an inspection of the facilities has been conducted to ensure compliance with the Directive and the CDSA and its associated regulations.

A Dealer’s Licence is required for each physical location where activities are conducted with controlled substances. All licensed dealers are required to have a secure environ for the storage of controlled drugs and substances, in accordance with the requirements of the Security Directive.

     Application requirements:

  • Corporate Applicants
  • Physical Security
  • Qualified Personnel
  • Confirmation of Controlled Substance
  • Production of Pharmaceutical Products
  • Record Keeping
  • Declaration signatures for each of designated person

How we can help you

Trichome Consulting Services will offer you advice and provide assistance on application writing, company planning, raising capital, navigating regulatory procedures, and obtaining the necessary licences for your activities.