Archived - Applying for a Drug Identification Number (DIN) for a disinfectant drug during the COVID-19 pandemic: Purpose and eligible products
Date of publication: 2020-11-04
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Purpose
In response to the increased demand for surface disinfectants, during the COVID-19 pandemic, numerous Canadian entities and industries have expressed interest in bringing licensed disinfectants to the Canadian market. These sponsors may be unfamiliar with the:
- application processes
- available pathways for product authorization
- requirements of the Food and Drug Regulations
A surface disinfectant is a substance or mixture of substances, capable of destroying or irreversibly inactivating, at a minimum, vegetative bacteria present on:
- inanimate objects
- environmental surfaces
- non-critical medical devices
Licensed disinfectants are denoted by a Drug Identification Number (DIN). We only issue a DIN for a finished product such as:
- a concentrate product that can be diluted
- a product that is packaged and sold ready-to-use
You must submit an application to obtain authorization to sell or import a surface disinfectant.
This document provides information on the application process and application contents for a disinfectant drug product regulated under the Food and Drug Regulations. It provides additional information on how to apply for a DIN and clarifies our existing processes and guidance. It does not replace any information in our existing guidance documents.
You must provide scientific evidence of a disinfectant’s safety, efficacy and quality before we authorize it for sale in Canada. This is required by the Food and Drugs Act and Regulations to determine whether the benefits associated with the product outweigh the risks.
Definitions of terms used in this guide are the same as those in section 1.6 of the Guidance document – Disinfectant Drugs (2020).
Eligible products
We regulate chemical products represented for use on environmental surfaces and inanimate objects such as cleaners, sanitizers and disinfectants according to their represented use or purpose, and not based on their chemical compositions. As a result, regulation of these products falls under a number of different frameworks.
In general, 2 key factors determine which regulatory framework is applicable to a product:
- the intended use as represented by the expressed or implied claims, including the level of antimicrobial activity on its label
- the intended type of surface or object to which it will be applied
Disinfectants captured by this guidance are for use on:
- non-critical medical devices
- hard non-porous environmental surfaces
- inanimate objects in domestic, industrial/institutional, hospital, food processing and/or barn premises
They are referred to as "hard surface disinfectants." Their labels may also have hard non-porous food and non-food contact surface sanitizer claims. In this case, they are referred to as "disinfectant-sanitizers”. A disinfectant-sanitizer is a chemical product represented for primary surface disinfectant uses and secondary uses as a sanitizer on environmental surfaces and inanimate objects.
Ineligible products
The Pest Management Regulatory Agency (PMRA) and Healthy Environments and Consumer Safety Branch (HECSB) regulate similar ingredients with different claims. For instance, products with bacteriostatic coatings meet the definition of a pest control product as per section 2(1) of the Pest Control Products Act (PCPA). For descriptions of some typical products regulated by PMRA and HECSB, please consult the Guidance document - Management of Disinfectant Drug Applications (2020).
The Medical Devices Directorate regulates high-level disinfectants/sterilants intended for use on reusable semi-critical and critical medical devices. Critical medical devices are introduced directly into the human body through:
- the penetration of mucous membranes or skin into normally sterile areas of the body or
- direct contact with the bloodstream (for example, surgical instruments) and for which reprocessing using sterilization processes is required
We recommend you reach contact the Medical Devices Directorate meddevices-instrumentsmed@hc-sc.gc.ca to determine if the disinfectant’s intended surface is a semi-critical or critical medical device.