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

6. Interpretation and Procedures

This section has been developed to assist applicants in filling out the "Test Kit Application Form". Please refer to the sections on the form.

SECTIONS 1, 2, 3 & 4: Manufacturer's and Distributor's Contact Information

The following information must be provided:

• manufacturer's name & address;
• name, title, telephone number and, if applicable, the fax number, e-mail address and mailing address (if different from manufacturer's address) of the person responsible for the Test Kit registration;
• Canadian distributor's name & address (if different from the manufacturer);
• name, title, telephone number and, if applicable, the fax number, e-mail address and mailing address (if different from distributor's address) of the person responsible for the Test Kit distribution.

SECTION 5: Test Kit Qualitative and Quantitative Description

NOTE: This section must be filled out separately for each Test Kit that the manufacturer wants to register.

A detailed description of the Test Kit must be provided, including:

• the brand name and catalogue number of the Test Kit;
• the name and quantitative details for each substance contained in the Test Kit, including the controlled substance(s), reagent system(s), buffering agent(s), adultering or denaturing agent(s), etc.

SECTION 6: Test Kit Use

NOTE: This section must be filled out separately for each Test Kit that the manufacturer wants to register.

The following information must be provided:

• a description of the proposed use of the Test Kit;
• a description of the design of the Test Kit;
• a description of and directions for the use of the Test Kit.

SECTION 7: Sample of the Product Label

NOTE: This section must be filled out separately for each Test Kit that the manufacturer wants to register.

A sample of the Test Kit product label must be provided. The label must include the following information:

• manufacturer's name and address;
• brand name of the Test Kit;
• Test Kit registration number location (i.e. where the T.K. number will appear once it has been issued).

SECTION 8: CERTIFICATION

The person applying for the Test Kit registration number must:

• certify that the information submitted in support of the application is correct and complete;
• sign the application.

NOTE: Test Kit registration number holders must notify the Minister in writing, within 30 days after the event, of any changes to the information in sections 1 to 7 or if the manufacturer has ceased all activities with respect to the Test Kit.

7. Submission

The application form and any attachments must be submitted to the:

Evaluation and Authorization Division
Office of Controlled Substances
Drug Strategy and Controlled Substances Programme
Healthy Environments and Consumer Safety Branch
Health Canada
A. L. 3503B
Ottawa, Ontario
K1A 1B9

The Test Kit Application form may be found on the Health Canada web site at http://www.hc-sc.gc.ca/hc-ps/substancontrol/substan/test-essai/test_kit_app-form_dem-eng.php, or may be obtained by contacting the Evaluation and Authorization Division by phone at (613) 952-2219 or (613) 957-1063, by fax at (613) 952-2196 or by email at exemption@hc-sc.gc.ca