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Applying for a Drug Identification Number (DIN) for a disinfectant drug during the COVID-19 pandemic: COVID-19-related application flexibilities

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COVID-19-related surface disinfectant flexibilities

To increase access to disinfectants in Canada, we have implemented interim measures. You can find details of these interim measures on our information for manufacturer’s webpage.

General COVID-19 flexibilities for all disinfectant application/submission pathways include:

  1. Expedited processing and/or review of submissions/applications that only contain direct or indirect SARS-CoV-2 claims. Please note this flexibility will only remain in effect until October 1, 2021.

    We will not expedite applications with multiple pathogen claims for review even though the application may also include efficacy data to support a direct or indirect SARS-CoV-2 claim.

    You can make a business decision on whether you want a product approved with:

    • multiple pathogen claims within a standard review time, or
    • limited claims with expedited review

    We will only expedite the following types of applications or submissions:

    • a Drug Identification Number for a Disinfectant (DIND) to change a previously licensed product or Supplement to a New Drug Submission (SNDS) with efficacy data only against SARS-CoV-2 or 1 acceptable surrogate virus to support indirect claim against SARS-CoV-2
    • a New Drug Submission (NDS) or new Drug Identification Number (DIN) application with efficacy data only for:
      • general/hospital disinfection claims (Staphylococcus aureus, and Salmonella enterica and/or Pseudomonas aeruginosa) and
      • direct or indirect COVID-19 claim, that has efficacy data against SARS-CoV-2 or 1 acceptable surrogate virus 
  2. Extending the time for you to respond to clarification requests for non-expedited review submissions or applications.

    We will extend the time for you to respond to a:

    • Notice of Deficiency
    • Notice of Non-Compliance

Adding a direct or indirect claim against coronavirus

Your disinfectants can only make a direct claim against SARS-CoV-2 when you have conducted efficacy testing against SARS-CoV-2 itself. An example of a direct claim would be “This product kills SARS-CoV-2 (the virus that causes COVID-19)”.

Your disinfectants can make an indirect claim against SARS-CoV-2 when you have conducted efficacy testing against an acceptable surrogate virus. A surrogate virus is an alternative microbe species or strain used to represent another, typically due to biosafety concerns, ease of culturing, and/or availability. An example of an indirect claim would be “This product kills Poliovirus Type 1 and is likely to kill SARS-CoV-2 (the virus that causes COVID-19)”.

You may submit an application, a DIND or SNDS, if you have data to support direct or indirect claims against SARS-CoV-2. The claims for a new or existing licensed product must be in accordance with the efficacy requirements:

Sourcing active ingredients from alternate sources

You may access alternate sources of active and inactive ingredients if you use the same concentration and are the same Chemical Abstracts Service (CAS) number.

Use of technical grade ethanol in surface disinfectants

We are allowing the use of technical-grade ethanol in disinfectants under the conditions outlined in Technical-grade ethanol for use in hand sanitizers and hard-surface disinfectants: Notice to industry. You cannot distribute your finished product until you receive a No objection letter (NOL).
To obtain this letter, you must submit a notification on the use of technical grade ethanol form with a copy of your bilingual product label to hc.rmd.coordination-dgr.sc@canada.ca, after receiving a DIN. We outline details on how to submit and complete this notification in the Interim guide on the production of ethanol for use in alcohol-based hand sanitizers: Technical-grade ethanol.

For more information on this flexibility, please refer to:

Suppliers of technical-grade ethanol for use in the production of hand sanitizers and hard-surface disinfectants

List of disinfectants for use against coronavirus

We have published a list of that have demonstrated that they are likely to be effective and that you may use against SARS-CoV-2.

How to get on the list:

  1. If you are a not the current holder of a DIN but have a product marketed through a licensing agreement (that is, you are a licensee), we can only add your product to the list if the licensor’s product has submitted supportive efficacy data and we considered it satisfactory.
  2. If you are a current holder of a DIN with broad-spectrum antiviral claims currently approved on the label resulting from a full drug review, and would like to be added to the list, please notify us at hc.nnhpd.consultation-dpsnso.sc@canada.ca. 
  3. If you are a current holder of a DIN but you have NO broad-spectrum antiviral claims, but are aware that you submitted data to support these claims (that is, data regarding an acceptable surrogate virus) as part of the original review of your submission, provide a link to the specific submission with the data and notify us at hc.nnhpd.consultation-dpsnso.sc@canada.ca.

Once confirmed, we will add your product to the list. You cannot submit new evidence for evaluation through the above process. This requires you to submit a DIND application to amend your product.

Please note that having a product on the list is not an approval to change the product label. Submitting a formal application to us allows you to change your disinfectant labels.

Submissions filed in accordance with the Hard Surface Disinfectants Monograph are ineligible to be added to this list. You must file additional efficacy data under the DIND full review stream in accordance with the efficacy requirements of the:

End of interim period

Health Canada will lift the interim measures when the regular supply stabilizes.

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