Service Standard for the Issuance of an Amendment to a Dealer's Licence for Controlled Substances

Service Description:

Health Canada posts service standards and performance information in accordance with the applicable Applications Management Policy (AMP) for services with over 100 regulatory authorizations, such as permits or licences, issued each year (high-volume regulatory transactions).

This service is a high-volume regulatory transaction used by applicants seeking to make amendments to their dealer's licence which do not require an on-site-inspection, including, but not limited to, the following:

• Add or remove activities that the licensed dealer conducts;
• Add or remove controlled substances that the licensed dealer uses in carrying out activities;
• Amend the quantity of controlled substance (raw material) produced within a given time period;
• Revise the legal name of the licensed dealer; and
• Amend the licensed dealer's address without a change in facility.

The diversion of controlled substances and precursor chemicals frequently used in the production of illegal drugs is a worldwide problem that requires a global solution. Health Canada is an active team player in the fight to control the illegal use of these controlled substances and precursor chemicals.

The Office of Controlled Substances (OCS) works in collaboration with Canadian and international stakeholders in the public and private sectors to ensure that controlled substances and precursor chemicals are handled effectively and remain in legal distribution channels, and that there is no interference with valid commercial, medical and scientific activities.

The Controlled Drugs and Substances Act (CDSA) prohibits certain activities with controlled substances and precursor chemicals - including possession, trafficking, importation, exportation and production - except as authorized by regulations. The Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations, are regulations under the CDSA, which set out detailed requirements for persons involved in carrying out activities with controlled substances, including the requirement to obtain a controlled substances licence before conducting certain activities. The licence authorizes the person to conduct the activities specified by the licence.

Service Standard:

The OCS commits to a service delivery standard, as per the applicable AMP, of 45 calendar days from the receipt of a complete application for issuing a decision on an application for an amendment to a dealer's licence for controlled substances (amendment approved/amendment refused).

Performance Target:

The target for achieving this standard is set at 90%.

Performance result in fiscal year 2020 to 2021:

The OCS processed 91% of applications within its service standard.

Departmental Contact:

Please contact the OCS to make any general enquiries or comments, or to receive application forms and additional guidance. Note that at any time, regulations supersede the guidance documents.

Controlled Drugs Section
Office of Controlled Substances
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada
Address Locator: 0300B
Ottawa ON K1A 0K9
Email: cds-sdc@hc-sc.gc.ca