Management of Biocide Applications: Review

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• The review process
• Cancellation during the review
• Solicited information during the review

The review process

The review period begins immediately after the Screening Acceptance Letter (SAL) is issued.

NNHPD assesses biocide applications within the performance standards specified in the Performance standards for biocide application section.

We evaluate whether the information submitted meets the requirements set out in the applicable sections of the Regulations.

Cancellation during the review

If you wish to cancel your application during the review, a letter requesting the cancellation should be sent to Health Canada (refer to filing of information to Health Canada), before a decision is made to issue any of the following:

• market authorization
• notice of acceptance (NOA)
• no objection letter (NOL)
• notice of deficiency (NOD)
• notice of non-compliance (NON)
• notice of deficiency – withdrawal (NOD-W) or
• notice of non-compliance – withdrawal (NON-W)

NNHPD will issue a cancellation acknowledgement letter.

You may cancel applications without having an impact on refiling. To determine the fee that will be invoiced for a cancelled application, refer to the guidance on evaluation fees for biocides.

Solicited information during the review

Solicited information is any information requested by NNHPD during the review of a biocide application. Examples of solicited information include responses to:

• clarification requests
• a notice of deficiency (NOD)
• a notice of non-compliance (NON)

Clarification request during the review

The purpose of a Clarification Request during the review is to seek clarification on specific information in the application regarding the biocide's risks, benefits, and any associated uncertainties (e.g., the safety, efficacy, and quality information). Examples of solicited information during the review may include the submission of a scientific rationale, or changes to proposed labelling.

NNHPD will send you the Clarification Request by email, and the timeline to respond varies with the application pathway (refer to Time to respond to a clarification request).

To clarify points of the Clarification Request, or why we sent it, you should contact the sender of the request.

There is no limit on the number of Clarification Requests that may be sent for one application. However, no particular issue will be addressed more than once.

Response to a Clarification Request during the review

The general information for responding to Clarification Requests is applicable to both the screening and review periods. For more information, refer to the previous Response to a Clarification Request during the Screening 1 period section.

During the review, if NNHPD determines that a response to a Clarification Request is not satisfactory or it is not submitted within the specified time to respond, you may receive the following:

• a Notice of Deficiency (NOD) where the review cannot be completed due to identified deficiencies (refer to the Notice of Deficiency (NOD) section) or
• a Notice of Non-Compliance (NON), where the review is considered to be non-compliant with the requirements outlined in the FDA and the Regulations (refer to the Notice of Non-Compliance (NON) section)

Pause the Clock during the review period

Pause the clock is a tool that allows the applicant to request that Health Canada pause the review clock under specified circumstances. When there is a pause, the target date is shifted to account for the amount of time the clock has been paused.

The clock can pause only during the review (e.g., Review 1 and Review 2) for cost-recovered applications. Applications received through the following pathways are excluded from this mechanism:

• Monograph
• Comparison – administrative
• Major change – monograph
• Major change – quality and risks
• Minor change
• Transition

You can only use pauses for biocide applications to request an extension to respond to a Clarification Request.

You should submit your extension request as soon as possible in the form of a letter and written rationale (refer to filing of information to Health Canada). The clock will pause if the following criteria are met:

• The extension request is beyond the number of days allocated to respond to a Clarification Request for the application pathway (as indicated in the Time to respond to a clarification request section of this guidance document)
• The extension request is a minimum of 5 days but not beyond 90 days per Clarification Request
• We approve your extension request in writing

Following our approval of the extension and after the standard clarification response time has elapsed, the review clock pauses. You have the additional time approved to respond to the clarification request, and the target date for the application is changed.

If the response to a Clarification Request is not satisfactory or not submitted within the specified time to respond, a NOD or NON will be issued (refer to the Response to a Clarification Request during the review section).

Notice of Deficiency (NOD) during the review – novel biocide and full review

A NOD will be sent to you when:

• we identify deficiencies or significant omissions that preclude continuing the review, or
• we identify novel aspects, and request that you file additional information to establish the unique benefits and risks of the biocide, and to address the uncertainties related to the biocide's novel characteristics.

At the time of the NOD issuance, all review streams will stop, and the status of the application will become inactive until we receive your response even if the review in the other streams has not been completed. We will only send one NOD per application. It will include all deficiencies identified to date from all review streams.

The difference between a NOD and a Notice of Non-Compliance (NON) is that the review of the application is not complete when a NOD is issued.

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

For all biocide applications, you should submit the response to a NOD within 90 calendar days (or such time as NNHPD and you may agree upon) from the date the NOD was sent.

Following the issuance of a NOD, we may send one of the following at the completion of the review:

• a Notice of Deficiency Withdrawal (NOD-W), for an application as a result of a failure to establish that the benefits associated with the biocide outweigh the risks associated with it, taking into account any uncertainties relating to the benefits and risks (refer to the Notice of Deficiency Withdrawal letter (NOD-W) section)
• a Notice of Non-Compliance (NON), for an application that is non-compliant with the requirements outlined in the FDA and the Regulations (refer to the Notice of Non-Compliance (NON) section)
• a market authorization containing the eight-digit identification number assigned to the biocide
• a Notice of Acceptance (NOA), for a major change application (refer to the Notice of Acceptance (NOA) section)

Response to a Notice of Deficiency (NOD)– novel biocide and full review

You should submit your Response to a NOD as per the filing of information to Health Canada section. The solicited information should include a copy of the NOD and be submitted in a question-and-answer format, with references to the applicable section(s) of the application.

When responding to a NOD, you should clearly identify:

• the name of the biocide
• the Dossier ID
• the control number of the relevant application, and
• the purpose of the correspondence (i.e., "Response to NOD") in the cover letter.

The response to a NOD should not contain unsolicited information (refer to the Unsolicited information section) unless otherwise specified in the NOD.

Should you decide it is not necessary to file the solicited information, a sound scientific rationale for this position must be presented for the response to be considered complete.

You should send all the requested information along with up-to-date documents including an updated cover letter in a single package for processing (refer to filing of information to Health Canada). All information received will be processed and sent to NNHPD within 10 calendar days.

Upon receipt of the information requested in the NOD, a new 45-day Screening 1 period will begin, and the requested material and information will be screened by NNHPD for completeness.

Acceptance letter following the response to a Notice of Deficiency (NOD)

If after screening we find the response to the NOD acceptable, we will send you a SAL and a new review (i.e., Review 1) period will begin immediately (refer to the Screening Acceptance Letter (SAL) section).

Notice of Deficiency Withdrawal Letter (NOD-W)

We will send you a NOD-W if:

• the Response to a NOD contains unsolicited information, is incomplete, or is deficient,
• you fail to submit the solicited information (i.e., the Response to a NOD), within the assigned time period
  • we will interpret this as a request to withdraw the application or
• during the review of the Response to a NOD, we determine that the application remains deficient.

If a NOD-W has been issued, the review of the application will stop and you may refile without prejudice.

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

Notice of Non-Compliance (NON) during the review – novel biocide, full review, use of foreign decisions (UFD), comparison – labelling only

A NON is issued by NNHPD when the review is complete, and the application is considered non-compliant with the requirements outlined in the FDA and the Regulations. The NON will specify the issues that make the submission non-compliant.

At the time of the NON issuance, the status of the application will become inactive until your response is received. We will only send one NON per application.

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

You must submit the response to a NON within 45 or 90 calendar days (depending on the application pathway) from the date the NON was sent.

Following the issuance of a NON, we may send you one of the following at the completion of the review:

• a Notice of Non-Compliance (NON-W), for an application that is non-compliant with the requirements outlined in the FDA and the Regulations (refer to the Notice of Non-Compliance (NON-W) section)
• a market authorization containing the eight-digit identification number assigned to the biocide
• a Notice of Acceptance (NOA), for a major change application (refer to the Notice of Acceptance (NOA) section)

Response to a Notice of Non-Compliance (NON)– novel biocide, full review, UFD, comparison - labelling only

You should submit a Response to a NON as per the filing of information to Health Canada section. You should include a copy of the NON, submit the information in a question-and-answer format and reference the applicable section(s) of the application.

When responding to a NON, you should clearly identify:

• the name of the biocide,
• the Dossier ID,
• the control number of the relevant application, and
• the purpose of the correspondence (i.e., "Response to NON") in the cover letter.

The response to a NON should not contain unsolicited information (refer to the Unsolicited information section) unless otherwise specified in the NON.

Should you decide it is not necessary to file the solicited information, you must include a sound scientific rationale for this position for the response to be considered complete.

You should send all the requested information along with up-to-date documents including an updated cover letter in a single package to Health Canada for processing (refer to filing of information to Health Canada). All information received will be processed and sent to NNHPD within 10 calendar days.

Upon receipt of the information requested in the NON, a new 45-day Screening 2 period will begin, and the requested material and information will be screened by NNHPD for completeness.

Acceptance letter following the response to a Notice of Non-Compliance (NON)

If the response to the NON is screened and found acceptable, we will send you a SAL and a new review period (i.e., Review 2) will begin immediately (refer to the Screening Acceptance Letter (SAL) section).

Notice of Non-Compliance Withdrawal Letter (NON-W)

We will send you a NON-W letter if:

• the Response to a NON contains unsolicited information, is incomplete, or is deficient,
• you fail to submit the solicited information (i.e., the Response to a NON) within the assigned time period
  • we will interpret this as a request to withdraw the application or
• during the review of the Response to a NON, it is determined that the application remains deficient.

If a NON-W letter has been issued, the review of the application will stop and you may refile without prejudice (refer to the Refiled Applications section).

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