Service standard for the issuance of a test kit registration number for test kits containing controlled substances

Service description:

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 obtain a test kit registration number for controlled substances.

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, sale and production - except as authorized by regulation. The Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and 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 test kit registration number for controlled substances before conducting certain activities.

Service standard:

The OCS commits to a service delivery standard of 45 calendar days from the receipt of a complete application for issuing a decision on an application for a test kit registration number for test kits containing controlled substances.

Performance target:

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

Performance result for fiscal year 2021 to 2022:

The OCS processed 11% 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
AL 0300B
Ottawa ON K1A 0K9
Email: cds-sdc@hc-sc.gc.ca