Archived - Applying for a Drug Identification Number (DIN) for a disinfectant drug during the COVID-19 pandemic: Prepare your application

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Application requirements for each disinfectant stream

These are the documents required for each disinfectant stream and pathway.

Monograph-based products: Drug Identification Number Application – Labelling Standard (LS) Application

Drug Identification Number Application – Disinfectant (DIND) (full review)

New Drug Submission (NDS) for disinfectants

Cross-licensed products: Administrative submission

Cross-licensed products: Labelling-only applications

Supplement to a New Drug Submission (SNDS)


A full list of Health Canada forms is accessible here: Forms: Applications and submissions for drug products

Outlines and templates

This section provides information that should be included in your cover letter and letter of authorization (for Administrative and Labelling-only applications/submissions using a cross-licensing pathway).

Cover letter

You must clearly state in your cover letter the contents and the reason for filing. In order to expedite your application, the cover letter must:

We requires certain information for all cover letters, you need to:

Letter of Authorization

Sample - Letter of Authorization (licensing agreement)

Dear Sir or Madam:

RE: (Name of Cross-licensed product)

(Licensor) hereby authorizes the licensee to reference, and Health Canada to access, (submission type), (Product name), (Control#), and subsequent drug submission or application updates for the product, in order to support the submission or application filed by (licensee) that will be processed administratively for their (product name).

(Licensor) certifies that (Licensee) (product name) will be manufactured, controlled and packaged as per (licensor) using the systems and procedures submitted and authorized by Health Canada.

We confirm that we have provided (Licensee) with the most complete and up-to-date submission or application information to: support the filing of an administratively complete submission or DIN application; support the development and maintenance of product labels for the cross-licensed product(s); and, to ensure consistency with that of the Canadian Reference Product, if applicable. We understand that failure to keep our product labels up-to-date may impact the approval of the licensee's drug submissions or applications.

As the licensor, we acknowledge our responsibility to ensure that:

Yours sincerely,

(Authorized signature - Licensor)

(Signee's Name and Title)

Your obligations

Your disinfectant products need to comply with all of the provisions under the Food and Drug Regulations. The sections below address only a subset of those requirements.


You are exempt from providing us with a copy of the mock-up of the labelling materials for your disinfectant products. While we may use a unilingual label text for the purpose of review, products are still required to comply with all of the labelling requirements under the Food and Drug Regulations (including the use of a bilingual label). You can find details of these labelling requirements in Section 2.4 Regulatory Labelling Requirements in the Guidance document – Disinfectant Drugs (2020).

Establishment licensing and good manufacturing practices (GMP)

If you fall under the parameters set out in section C.01A.002(1)(e) of the Food and Drug Regulations, you're not required to:

These disinfectants must meet the definition of an "antimicrobial agent" (that is disinfectants represented for use on non-critical medical devices, environmental surfaces and inanimate objects).

We still expect you to meet the provisions of section 8 of the Food and Drugs Act. To support compliance with this regulatory requirement, we developed a voluntary standard for antimicrobial agents for use on environmental surfaces and certain medical devices. We encourage you to review and apply this standard where possible.

We expect you to be in a position to provide the following information to support a proposed disinfectant, either within the disinfectant drug application or submission or upon request. This information includes a description of:

For devices, we issues Medical Device Licenses (MDL) and Medical Device Establishment Licenses (MDEL) for the activities of importing or distributing (selling) medical devices for human use in Canada.

Post-market obligations

You are required to conduct certain post-market activities following the approval of a disinfectant. You can find details of those activities in the:

Checklist before submitting your application/submission

A high-quality application or submission facilitates the review of the product and reduces the time for granting a market authorization.

High quality applications or submissions feature:

Note: No broad spectrum virucide claims, pathogen specific claims (direct or indirect COVID-19 claims) are permitted in the absence of data (e.g. monograph submissions)

During the COVID-19 pandemic, we have noticed the following common deficiencies:

You may find details of these aspects and others in these documents:

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