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

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Fees

For every submission and application, you must select the applicable fee category on the Regulatory Enrolment Process (REP) regulatory transaction template.

We use the fee category to classify your submission. If your submission or application documents do not correspond with the fee category selected, your submission or application may be rejected or delayed.

Do not include advance payment when filing the submission. We will review the form and issue an invoice. We typically issue an invoice when we accept the application into review. Regardless of when we issue the invoice, payment is due 30 days from the date of issuance.

Fees increase each year to align with inflation. A full listing of current fees is in Fees for Examination of a Submission: Drugs for Human Use. Please use the latest version of the fee form.

For more guidance on fees and small business flexibilities, please consult the Guidance Document: Fees for the Review of Human and Disinfectant Drug Submissions and Applications.

The drug right-to-sell fee is an annual fee for the right to maintain a drug on the Canadian market. This fee also applies to disinfectants.

Determine your application stream

There are different application streams based on whether you would like to:

There are a number of pathways used to seek an authorization for a disinfectant product.

New disinfectant drug product authorization

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

Relevant Division of the Food and Drug Regulations: Part C, Division 1
Fee class: Drug Identification Number application, labelling standard

You can submit a Drug Identification Number Application for a Disinfectant (DIND) attesting to the monograph if your product is completely in accordance with the Hard Surface Disinfectants Monograph including its:

You cannot add pathogen-specific claims through this pathway due to lack of product specific efficacy data.

Although you are not required to submit supporting data with your application, we expect you to:

Drug Identification Number application – Disinfectant (DIND) (full review), applications with data (those outside the monograph pathway)

Relevant Division of the Food and Drug Regulations: Part C, Division 1
Fee class: Disinfectant, full review

You are required to submit evidence about safety and efficacy when a proposed disinfectant or its labelling is outside the scope of a published monograph. These applications require a scientific assessment as part of their market authorization.

You are not required to submit evidence about its quality as part of the application process for disinfectants regulated under Division 1 of the Food and Drug Regulations.

We expect you to:

New Drug Submission (NDS) for disinfectants

Relevant Division of the Food and Drug Regulations: Part C, Division 8
Fee class: Disinfectant, full review

You can apply for an authorization through a DIND application for most disinfectant drug products. However, some submissions for surface disinfectants need to follow the NDS pathway if they meet the definition of a new drug. Features that may require a NDS application include:

For example, we would consider anti-biofilm claims and use of nano-technology through this pathway.

These applications require filing evidence for quality, safety and efficacy. If you believe your product meets the criteria of this application pathway, we encourage you to contact a regulatory project manager at hc.nded-demvso.sc@canada.ca. The regulatory project manager will help you determine the most appropriate information to include in your application.

Cross-licensed products

You can obtain a Drug Identification Number (DIN) through a cross-licensing agreement to a previously authorized product. The cross-licensed products must have the same formula as the Licensor’s product and must include a Letter of Authorization from the Licensor.

There are 2 types of cross-licensed product authorization pathways:

You need to submit an administrative application or submission if the product’s labelling is the same as that of the licensor. You must follow the administrative pathway in accordance with the criteria set out in the Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs.

You need to submit a labelling-only application or submission if the product’s labelling is different than that of the licensor. 

Administrative application or submission

Relevant Division of the Food and Drug Regulations: Part C, Division 1 or Division 8
Fee class: Administrative submission or application

The administrative submission pathway requires a review of:

All aspects of the drug submission, including labelling materials need to be identical to those of the licensor, with the exception of the product name and DIN holder’s name.

For information regarding administrative application or submission requirements, consult the relevant documents:

Labelling-only applications

Relevant Division of the Food and Drug Regulations: Part C, Division 1 or Division 8
Fee class: Labelling-only (disinfectants)

Labelling-only applications require a review of the labelling materials for the product. There is no requirement to submit supporting data for quality, safety or efficacy with the exception of information to support safety updates as part of Division 8 requirements.

Changes to authorized disinfectants

You may wish to make changes to the disinfectant or the information associated with the disinfectant. Changes to disinfectants need approval from us prior to implementation or be subject to a notification.

We encourage you to review the relevant guidance documents regarding Post-DIN changes (for Part C, Division 1 products) and Post Notice of Compliance (NOC) changes (for Part C, Division 8 products):

In order to add a new claim to a product, you should file a DIND application for a Division 1 product or a Supplement to a New Drug Submission (SNDS) for a Division 8 product.

Addition of claims for approved monograph disinfectants: DIND Monograph Labelling Standard application  

Relevant Division of the Food and Drug Regulations: Part C, Division 1
Fee class: Disinfectant full review

For products licensed through a DIND Monograph Labelling Standard application, you cannot add pathogen-specific claims post-licensing. If you wish to add pathogen-specific claims, you must submit a new DIND (full review).

For adding a claim to a product previously attesting to the monograph, you need to submit efficacy data to establish a general/broad-spectrum or hospital/healthcare disinfectant. This is described in the Guidance Document: Safety and Efficacy Requirements for Hard Surface Disinfectants (2020). Once you have submitted this data, we will determine if the product can market the pathogen-specific claim. Please consult the DIND (full review) application process.

Efficacy testing must reflect the method of application for the product. Please consult the Guidance Document: Disinfectant Drugs (2020) for special test requirements. For example, an application for a disinfectant wipe product should include studies or tests using a wipe or towelette product. You must test products used for fogging under the conditions of fogging and for electrostatic sprayers by applying the product with these sprayers. If you are unsure of the data requirements to support the review of a method of application, we advise you to contact us at hc.nded-demvso.sc@canada.ca to discuss data requirements.

Addition of claims for approved Division 1 disinfectants: Drug Identification Number application – Disinfectant 

Relevant Division of the Food and Drug Regulations: Part C, Division 1
Fee class: Disinfectant, full review

For a product previously licensed through a DIND application (full review), you must file a new DIND application with supporting data for the desired change before the change is implemented. If acceptable, we will issue a new DIN or retain the active DIN and issue a No Objection Letter for the changed disinfectant.

Addition of claims for approved Division 8 disinfectants: Supplement to a New Drug Submission (SNDS)

Relevant Division of the Food and Drug Regulations: Part C, Division 8
Fee class: Disinfectant, full review

For a product previously licensed through a Disinfectant New Drug Submission, you need to file a Supplement to a New Drug Submission (SNDS).

Addition of claims for approved cross-licensed disinfectants: Administrative or Labelling-only submission

Relevant Division of the Food and Drug Regulations: Part C, Division 1 or Division 8
Fee class: Administrative or Labelling-only (disinfectants) application or submission

For products that were previously licensed through cross licensing, you may file an Administrative drug submission or a labelling-only (disinfectants) submission to update the product’s labelling to align with the updated labelling materials of the cross-licensed product.

You need to submit an administrative submission if the product’s labelling (licensor and licensee’s products) are the same. In this case, we will issue the licensee’s DIN through an administrative licensing agreement.

You need to submit a labelling-only (disinfectants) submission if the licensee’s product labelling is different than the licensor’s product labelling. In this case, we will issue the licensee’s DIN through a non-administrative licensing agreement.

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