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Management of Biocide Applications: Completion of assessment

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Decision documents

Upon completion of an application and NNHPD recommends a decision (either negative or positive), we will send you one of the following decision documents:

Market Authorization – all pre-market applications

When we complete the assessment of a pre-market application and determine it complies with the Food and Drug Act (FDA) and the Regulations, we will issue you a market authorization for the biocide in accordance with subsection 12(1) of the Regulations that contains the eight-digit identification number assigned to the biocide.

No Objection Letter (NOL) – Minor changes

When we complete the assessment of a minor change notification and determine it complies with the FDA and the Regulations, you will receive a No Objection Letter (NOL). As applicable, we will update the market authorization and issue it to you in accordance with paragraph 17(4)(a) of the Regulations.

Notice of Acceptance (NOA)– Major changes, including post-authorization changes filed via comparison - administrative, monograph, UFD and comparison - labelling only pathways

When we complete the assessment of a major change application and determine it complies with the FDA and the Regulations, you will receive a Notice of Acceptance (NOA). As applicable, we will update the market authorization and issue it to you in accordance with paragraph 16(2)(a) of the Regulations.

Not Satisfactory Notice (NSN) – Minor Change

When we complete the assessment of a minor change notification and we have identified deficiencies, an NSN will be sent to you by NNHPD specifying the deficiencies.

To clarify points of the NSN or why we sent it, you should contact NNHPD by e-mail at nnhpd-dpsnso@hc-sc.gc.ca.

If an NSN has been issued, the assessment of the application will stop on the date it is sent, and you may refile without prejudice.

You may file a request for reconsideration following the issuance of an NSN (refer to the Reconsideration of decisions issued for biocide applications section).

Screening Rejection Letter (SRL) – All pre-market application pathways and major changes, including post-authorization changes filed via comparison - administrative, monograph, UFD and comparison - labelling only pathways

When we complete the assessment of all pre-market and major change applications, and we identify deficiencies, or if you fail to provide a response to an SDN within the assigned time period, an SRL will be sent to you by NNHPD specifying the reasons for rejecting the application.

To clarify points of the SRL or why we sent it, you should contact NNHPD by e-mail at nnhpd-dpsnso@hc-sc.gc.ca.

If an SRL has been issued, the assessment of the application will stop on the date it is sent, and you may refile the application without prejudice.

You may file a request for reconsideration following the issuance of an SRL (refer to the Reconsideration of decisions issued for biocide applications section in this guidance).

Notice of Deficiency - Withdrawal (NOD-W) – full review, novel biocide

If deficiencies and significant omissions persist following the issuance of an NOD, or if you fail to provide a response to an NOD within the assigned time period, a NOD-W will be sent to you by NNHPD specifying the reasons for rejecting the application. The assessment of the application will stop on the date the NOD-W is sent.

To clarify points of the NOD-W or why we sent it, you should contact NNHPD by e-mail at nnhpd-dpsnso@hc-sc.gc.ca.

Notice of Non-Compliance - Withdrawal (NON-W) – full review, novel biocide, comparison - labelling only, UFD

If the assessment of an application has been completed and is non-compliant with the requirements outlined in the FDA and the Regulations, a NON-W will be sent to you by NNHPD.

The NON-W will specify the issues from all the review streams that render the application non-compliant. The review of the application will stop on the date the NON-W is sent.

To clarify points of the NON-W or why we sent it, you should contact NNHPD by e-mail at nnhpd-dpsnso@hc-sc.gc.ca.

Unsolicited information

If unsolicited information is filed during the application, you will be asked to remove those documents by filing a new transaction to withdraw the unsolicited information.

If you wish to include removed unsolicited information in a future biocide application, it will need to be resubmitted as a new application and will be assigned a new control number.

Change in the name of the market authorization holder/applicant or the biocide's brand name(s) during the assessment

For a new biocide that has not yet been issued a market authorization, a change in the name of the applicant or the biocide's brand name(s) will be accepted at any point during the assessment.

The following should be submitted by filing a new transaction:

If a biocide has already received a market authorization and the name of the holder or biocide changes during a subsequent application, you must file a minor change to make the necessary changes (refer to the Guidance document for post-authorization changes for biocides).

Refiled applications

A refiled application is an application that you file following:

In all cases, a refiled application is considered to be a new application and will be assigned a new control number, a new filing date and managed in accordance with this guidance. A refiled application is subject to Health Canada policies, procedures and guidance documents that are in effect at the time of refiling, and you must update the application accordingly. A new dossier ID might be required in some circumstances prior to re-filing the application (refer to filing of information to Health Canada section).

You will be required to resubmit all information for the refiled application. Referencing the original application may be acceptable, if a comprehensive summary is submitted for the refiled application, to:

To increase the efficiency of the assessment, you should clearly identify both the new and the original information that is resubmitted.

The performance standards and fees in effect at the time of the refiled application for the relevant biocide application pathway will apply.

Send refiled applications as per the filing of information to Health Canada section, along with up-to-date documents (e.g., an updated cover letter and the BAF).

Reconsideration of decisions issued for biocide applications

Reconsideration is a dispute resolution process designed to ensure that negative decisions were made in accordance with existing scientific and regulatory standards. The process is designed to look at the information in specific applications rather than address complaints about perceived systemic issues.

We will try to identify, manage, and resolve disputes at the level at which they take place. Dispute prevention and early resolution will primarily take place through communication between NNHPD and applicants.

If mechanisms for early dispute resolution are not successful, you may file a formal request for reconsideration of a decision (refer to filing of information to Health Canada) in accordance with the Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions and Natural Health Products.

You may request a reconsideration following the issuance of the following decisions:

Issues not eligible for reconsideration are decisions based on applications containing documented falsified information, allegations of bias, and complaints about the application management process. Issues of this nature should be addressed to NNHPD's Biocides Review Team.

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