Guidance Document: Registration of a Test Kit for Medical, Laboratory, Industrial, Educational or Research Purposes

8. Application Review and Issuance of a Test Kit Number

The Office of Controlled Substances will screen the application and, if applicable, inform the applicant of any missing information. Once complete, the application will be reviewed to determine whether:

• the proposed activities for the Test Kit are solely for medical, laboratory, industrial, educational, or research purposes;
• the Test Kit poses no significant security, public health, or safety hazard, including the risk of the controlled substances being diverted to an illicit market or use;
• the Test Kit contains quantities or concentrations of controlled substances such that they have no significant abuse potential;
• the adulterating or denaturing agent in the Test Kit is likely to prevent or deter the consumption of the controlled substance in the Test Kit by a human or animal or the administration of that substance to a human or animal.

A Test Kit registration number will be issued if the product meets all of the above requirements.

9. Cancellation

A Test Kit registration number may be cancelled under the following circumstances:

• the manufacturer has ceased all activities with respect to the Test Kit;
• the Test Kit is being used for a purpose other than for a medical, laboratory, industrial, educational or research purpose;
• circumstances have changed and the Test Kit is found to pose a significant security, public health or safety hazard, including the risk of the controlled substance being diverted to an illicit market or use.

In the case of a Test Kit registration number cancellation:

• the cancelled Test Kit registration number must not be displayed on the label of any Test Kit made or assembled after the cancellation;
• in the case that a manufacturer has ceased all activities with respect to the Test Kit, the cancelled Test Kit registration number must remain on the label of any existing Test Kit until all of the Test Kits with that registration number have been disposed of;
• the applicant may, after a period of 90 days following the cancellation, apply to the Minister for the issuance of a new Test Kit registration number; in this circumstance, the applicant must provide the Minister with proof that the circumstance(s) that gave rise to the cancellation has(have) been corrected.