The requirements for licensing in Canada are set out in the Controlled Drugs and Substances Act (CDSA) and its associated regulations. You can access the Act and regulations on the following Web sites:
To legally own and operate with controlled substances in Canada, companies and research organizations must first obtain a controlled substance licence (or an exemption in specific cases). The licence authorizes the company or organization to possess the controlled substances and to carry out activities specified in the licence (production, packaging, sale, shipment, transport and delivery).
Controlled substances can only be imported or exported if the shipment is authorized by a permit issued by Health Canada. Only an authorized dealer licensee may apply for a permit.
The Office of Controlled Substances follows a service delivery standard of 180 working days from the date of receipt of a completed application to make a decision on a new controlled substance licence. However, the processing period for a licence application depends largely on the submission of complete and accurate information.
All authorized distributors must have a security framework for the storage of controlled drugs and substances. A description of each of the 11 security levels and its requirements can be found in the Directive on Physical Security Requirements for Designated Substances (Security Directive) (attached). Safety levels are determined by the geographical location, type and total quantity of controlled drugs and substances to be stored on the premises at a given time. Please read the directive carefully to determine the desired level of security for your license.
Attached is a self-compacting file with a template to be completed for each security level; you must complete and submit the template corresponding to your desired security level with your license application.
A licence can only be issued after all requirements of the CDSA and associated regulations have been met. Once your licence application has been fully reviewed, an inspection of your facilities will be conducted to ensure compliance with the Safety Directive and the CDSA and its associated regulations.
The fees associated with a controlled substance licence could be as high as $5184, depending on the drugs and substances that appear on your licence.See more
Fees are explained at the beginning of the application; however, please note that applicable fees are deferred to the end of the first full calendar year of licensed activities.
For a new Controlled Drugs and Substances Licence application or an amendment application, an “Acceptance of Application” email will be issued by our office. If you have not received the “Acceptance of Application” e-mail within 10 business days from the date of receipt, please send an email to email@example.com to request a status update.
Please do not send duplicate questions by way of other methods (e-mail, mail, phone call or facsimile) or to different e-mail accounts.
If you are a dealer licence holder, please indicate your 4-digit licence # in the subject line of all email correspondence sent to our Office.
The Office of Controlled Substances (OCS) strives to meet the following published service standards, from the receipt of a complete application to the date a decision is issued:
New Applications: 180 business days
Licence Amendments: 30 business days
Licence Renewals: 60 business days
Import and Export Permits: 30 business days
For more detailed information concerning OCS service standards, please visit the following link: See more
During the review, OCS may issue e-mail clarification requests or additional information requests. The service standards indicated above do not include the time OCS is awaiting a complete response to be submitted by the applicant (i.e.: the clock “stops” following the issuance of a request for clarification or information and does not resume until a complete response is submitted by an applicant).
You may submit a status request to this email address if you have not received your licence/permit by the prescribed timelines indicated above. It is the applicant’s responsibility to submit applications in advance of a need.
For more information, please visit our website at: See more
For timely processing, please ensure your inquiry has been submitted to the appropriate division. Please refer to the table below for information on where you may be required to direct your inquiry:
|If your request pertains to:||Please send your request directly to:|
|Access to Cannabis for Medical Purposes Regulations (ACMPR)||OMC-BCM@hc-sc.gc.ca|
|Use of controlled drugs or substances for in-vivo firstname.lastname@example.org|
|Loss and theft or reporting of unusual orders of controlled drugs or substances (including oxycontin)||OCS_Reporting_Rapporter_BSC@hc-sc.gc.ca|
|No Objection Letters (NOL) for the importation or exportation of controlled drugs or email@example.com|
|Destruction of controlled drugs or firstname.lastname@example.org|