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

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 at http://www.canada.justice.gc.ca