License Overview

For Legally Possessing And Conducting The Above Activities With Controlled Substances In Canada

  • Research organizations and companies must first need to obtain a controlled substances Dealer’s License 
  • Or a Section 56 exemption for researchers (veterinarians, physicians and other researchers associated with private industry and universities), requiring a controlled substance for research purposes that include administration to animals, in vitro utilization, or human clinical trials.

A Dealer’s License Permits An Organization Or Company To Possess A Controlled Substance And Conduct Activities Specified By The License. These Activities Can Be 

  • Packaging
  • Production
  • Transportation
  • Sending
  • sale
  • Delivery
  • Laboratory analysis
  • Research & development
  • Clinical studies
  • Import/export
  • Distribution under special access program only
Remember that imports and export of controlled substances online are allowed only when the shipment is authorized by a permit issued by Health Canada. Only those with a valid controlled substances Dealer’s Licence can apply for the import/export permit. All Licensed Dealers need to have a secure environment to store the controlled substances as specified on their licence. The level of security needed for the secure environment is decided based on the geographical location of the site (indicated in the licence) as well as the type and entire quantity of controlled substances that will be stored on the premises at any given time. A licence is only issued after all CDSA prerequisites and its regulations are met.

A Dealer’s Licence will only be issued after Health Canada’s Office of Controlled Substances (OCS) reviews a complete licence application package and the facility inspection is conducted to ensure it adheres to the Directive and CDSA and its associated regulations.

The Office of Controlled Substances is committed to a service delivery standard of 270 calendar days to issue a decision on an application for a new Dealer’s Licence for controlled substances, from the date of receipt of a complete application. However, the time period to possess an application majorly depends on the submission of complete and accurate information.

Applications for a Dealer’s Licence need to submit the following:

  • Dealer’s Licence application form
  • Corporate documentation
  • Physical Security documents (floor plan, security template, security proposal)
  • Senior Person in Charge (SPIC) Identification
  • Identification of a Qualified Person in Charge (QPIC) and any alternates (A/QPIC)
  • Documents in support of the QPIC – e.g. curriculum vitae, copy of degree, course transcripts, Canadian equivalency (if required)
  • Description of record-keeping method
  • Criminal Record Check or Police Check for QPIC, SPIC, and A/QPICs if any
  • Fee payment (up to $5,288) if suitable, based on the substances that need to be listed on the licence

If you are considering securing a Dealer’s Licence to work with a controlled substance, reach out to us today and let us help you get you started on the way to success!

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