Service Standard for Issuance of an Amendment to a Dealer's Licence for Controlled Substances
Disclaimer: Information on this webpage is provided for illustrative purposes only. The Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations, made under the Controlled Drugs and Substances Act should be relied upon for specific requirements, including if there are discrepancies between this page and the regulations.
Health Canada posts service standards and performance information 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 the licensed dealer proposes to conduct;
- Add or remove controlled substances that the licensed dealer proposes for use in carrying out activities;
- Add or remove products that contain the controlled substances (research preparations for clinical trials, medications approved for sale in Canada, etc.);
- Replace the company making or assembling products for the licensed dealer;
- Amend the quantity of substance 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 works in collaboration with Canadian and international stakeholders in the public and private sectors to ensure that controlled substances 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 - 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.
The Office of Controlled Substances (OCS) commits to a service delivery standard of 45 calendar days for the issuance of a decision on an application for an amendment to a dealer's licence for controlled substances, from the receipt of a complete application.
The target for achieving this standard is set at 90%.
Performance result in fiscal year 2017 to 2018:
The Office of Controlled Substances processed 73% of applications within its service standard.
Please contact the Office of Controlled Substances 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
Ottawa ON K1A 0K9
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