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

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

Cover letter
Canadian labelling materials such as labels and package inserts, as applicable
Regulatory Transaction (RT) XML
Product Information (PI) XML
Non-prescription drug monograph attestation form

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:

highlight the product is intended for COVID-19 in the subject line
be supported by product specific efficacy data for direct or indirect claims against SARS-CoV-2

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

clearly state what is being provided and the reason for filing as per the Regulatory Transaction Description document
indicate the:
- brand name
- dossier identifier
- regulatory activity type
- control number (if known)
- sequence number (for transaction in eCTD format only)
- stakeholder name and role, that is, sponsor, manufacturer, DIN holder or agent
include reference to a correspondence or a request letter issued by us (including an Advisement Letter), if applicable
clearly state any cross-referenced regulatory activity (include the date the regulatory activity was approved)
indicate the contact name and email address where the validation report (if required) should be sent
include a list of eligible patent claims and a description of how such claims correspond to the regulatory activity in respect of which the patent list is filed, as well as page references to relevant portions of the drug submission should be included, if applicable
include detailed information regarding the following transactions:
- other sale notifications (SN):
  - notifications of interruption of sale should indicate the:
    - DIN(s) affected
    - date the sale of the drug stopped (the cover letter should indicate that the product has not been sold for a period of 12 consecutive months)
  - notifications of discontinuation of sale (DIN cancellation) should indicate the:
    - DIN(s) to be cancelled
    - discontinuation date
    - expiry date of the last lot sold
    - lot number of the last lot sold
  - special requests - Drug Notification Form (DNF)
- responses to requests for clarification should clearly indicate the name of the requester
- Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER) (when provided to the Marketed Health Products Directorate) should also indicate which of the following applies:
  - significant change in what is known about the risks and benefits of the health product
  - voluntary PSUR/PBRER, unsolicited information
  - requested periodic PSUR/PBRER, requested by Health Canada (for example Risk Management Plan follow-up or post-authorization commitment)

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:

Product labels are kept up-to-date and any safety and efficacy updates are communicated to the licensee upon approval.
Any post-authorization updates to the chemistry and manufacturing data and product formulation are communicated to the licensee.

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.

Label

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:

obtain an establishment license
meet GMP compliance requirements for disinfectants in Division 1 and Division 8

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:

the formulated product, including:
- the source and specifications for the product's active ingredients and inactive ingredients
- the location(s) of manufacture of the product, that is, where the finished product is fabricated/produced
- their status within Canada's Domestic Substances List (DSL) and the Natural Health Products Ingredient Database (NHPID)
- their compliance with the Canadian Environment Protection Act (CEPA 1999). For example, sponsors are required to submit a New Substance notification under CEPA separately, if one of the ingredients (active or inactive) meets the definition of a new substance.
- each chemical ingredient by its proposed chemical name and CAS (Chemical Abstract Service) number
the proposed shelf life, and a confirmatory rationale regarding the considerations and stability testing conducted to determine the stability of the formulation
any proposed formulation variants, and their impact on the safety and efficacy profile of the product

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:

all necessary forms, documents and evidence, including the monograph or data
efficacy data that represents the intended uses or purposes of the product:
- as indicated on labelling materials
- when used in accordance with the label's recommended conditions for use.

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)

labelling that represents the potential safety hazards associated with a product when used and stored in accordance with the label's recommended conditions of use
efficacy data and/or safety data presented in a full study report as well as in a summary report. While a summary report is not mandatory, it may assist our review of the efficacy data, particularly when you summarize efficacy data in a table
the use of Good Laboratory Practice principles when producing safety and efficacy data
the use of test methods and protocols supported by regulators and scientific organizations

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

incorrect fee category selected on the fee form
deviations from the criteria outlined in the Hard Surface Disinfectants monograph for those using the monograph stream

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

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2024-06-11

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

On this page

Application requirements for each disinfectant stream

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)

Amendment/PDC/NC