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

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Table of Contents

1. Purpose
2. Background
3. Scope
4. Definitions
5. General Application Information
6. Interpretation and Procedures
7. Submission
8. Application Review and Issuance of a Test Kit Number
9. Cancellation

1. Purpose

The purpose of this document is to provide guidance to applicants of a Test Kit registration number as it pertains to the Controlled Drugs and Substances Act (CDSA) and its Regulations, and to the Food and Drugs Act and its Regulations.

2. Background

Regulation of controlled drugs and substances in Canada.

Health Canada is a national and international partner in the management of controlled drugs and substances through the administration of the CDSA and its regulations. Canada is also a signatory to the following international treaties: the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 protocol, the 1971 Convention on Psychotropic Substances, and the 1988 United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

By enacting the CDSA, Parliament has prohibited certain activities in relation to substances that are included in schedules to the Act. The regulations made under the CDSA authorize some activities to be done by specified individuals in the manner described in the regulations. One of these activities is authority to issue a registration number for a Test Kit. Pursuant to section 6 of the Narcotic Control Regulations, to section G.06.002.3 and J.0.033.3 of the Food and Drug Regulations and to section 72 of the Benzodiazepines and Other Targeted Substances Regulations, the Minister may issue a registration number for a Test Kit if the applicant has demonstrated that the Test Kit is designed to be used solely for a medical, laboratory, industrial, educational or research purposes and the Test Kit does not pose a significant security, public health or safety hazard, including risk of the controlled drug or substance being diverted to an illicit market or use.

Acts and Regulations can be found on the  Department of Justice web site.

3. Scope

This document is meant to provide guidance to manufacturers applying to the Minister for a Test Kit registration number.

This is a guidance document only. It is meant to clarify the broad terminology found in the CDSA and its Regulations and to explain the application process to obtain a Test Kit registration number.

4. Definitions

Clarification is being provided in this section for some of the terms used in this document. Definitions in the Act and its Regulations supersede any given in these Guidelines.

a "Test Kit" is a kit

• that contains a controlled substance;
• that contains a reagent or buffering agent, or both;
• that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational, or research purposes; and
• the contents of which are not intended or likely to be consumed by or administered to, a human or an animal.

a "Controlled Substance" is any substance included in Schedule I, II, III or IV of the CDSA

"To sell" includes any of the following activities, whether or not the distribution is made for considerations:

• offering for sale;
• exposing for sale; or
• having in possession for sale and/or distribution.

5. General Application Information

Who may apply for a Test Kit Number:

• a manufacturer who makes or assembles a Test Kit.

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, 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

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.