Veterinary drugs - Management of regulatory submissions guidance: Submission-related processes

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Procedure for sending regulatory submissions and related information

Sponsors should send all submissions to the VDD in electronic-only format as per Guidance Document: Preparation of Drug Regulatory Activities in the Non-eCTD Electronic-Only Format. Sponsors may use e-mail if the file size is less than 20 MB.

The VDD strongly encourages the use of the regulatory enrolment process (REP), which allows the filing of submissions via the common electronic submission gateway (CESG), for submissions that are within scope of REP.

Sponsors wishing to file via REP can consult the REP guidance documents or e-mail eReview@hc-sc.gc.ca for information on procedures and guidances in effect at the time of filing.

To discuss alternate methods of submission filing, please contact the Submission and Knowledge Management Division (SKMD) at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

Submission holds

The VDD may place a submission on hold at various stages of the submission process. In the case of a submission hold, the VDD will inform the sponsor of the reason and the possible solutions (if available).

During initial processing

The VDD will place the submission on hold if the information received in a submission does not meet all applicable administrative requirements, for example:

The VDD will send an e-mail to the sponsor to:

The VDD may reject the submission if the sponsor does not provide a response to the VDD within the time specified. The official date of receipt will be when the submission is administratively complete. This will be considered the filing date.

During screening, review and the notice of compliance (NOC) and/or DIN issuance stage

The VDD may place a submission on hold in certain situations that prevent further review or issuance of a decision. These situations may include:

Pre-submission phase

Consultation: pre-submission

Before filing a submission, the sponsor should consult the applicable guidance documents. For a product that is already approved, the sponsor should refer to the applicable post-NOC guidance documents to ensure that the proposed change qualifies for the submission type under which the sponsor plans to file. In cases where available VDD guidance does not cover all aspects of an intended submission, a pre-submission meeting may be useful to the sponsor.

Classification

The sponsor may need guidance on the classification of their product, for example, whether it would be regulated as a new drug, not new drug, VHP, feed, pesticide, etc. In this case, the sponsor should send a request for product classification to the VDD at classification-vet@hc-sc.gc.ca.

For inquiries related to submission classification (for example, SNDS versus NC), the sponsor may send a request for regulatory guidance to the VDD via e-mail. Sponsors should provide adequate information to enable the VDD to assess the significance of the changes proposed without the need for further clarification from the sponsor.

It is the sponsor's responsibility to provide adequate supporting data for the proposed change in order to demonstrate that the changes do not pose any adverse impact on:

The VDD will:

Pre-submission meeting

Requesting a pre-submission meeting

Before filing a submission, the sponsor may request a pre-submission meeting with the VDD to seek regulatory guidance on specific items. The purpose of the meeting would be to:

Pre-submission meetings are not intended for presentation, discussion and pre-evaluation of actual data that have been generated from studies conducted by the sponsor. They are meant to provide further clarification and guidance on the type of studies and data needed in support of the submission.

The sponsor can send a meeting request to the VDD at any time. It takes approximately 60 calendar days to set up a pre-submission meeting from the date of the request. The sponsor should consider this time when planning to request a pre-submission meeting with the VDD.

The sponsor should send the meeting request to the VDD by e-mail using the pre-submission meeting request template located on our Forms - Applications and submissions - Veterinary Drugs website.

The sponsor should provide adequate product-related information to enable the review divisions to assess the meeting request and to select appropriate meeting attendees from the VDD. The VDD will log the meeting request and assign it a submission number.

Upon confirmation of the pre-submission meeting date, the VDD will notify the sponsor by e-mail. The sponsor needs to provide a pre-submission meeting package in electronic copy via e-mail by a specified date.

Pre-submission meeting package

Sponsors should note that pre-submission meetings are limited to 2 hours including a slide presentation (if any) of no longer than 30 minutes. When submitting pre-meeting packages, the sponsor should ensure the information submitted is sufficient to allow the appropriate feedback from the VDD. The VDD recommends the package be limited to 40 pages. It should contain:

Following the pre-submission meeting

After the pre-submission meeting, the sponsor needs to provide the VDD with a draft copy of the minutes of the meeting via e-mail within 2 weeks. The meeting minutes should include:

Upon receipt of the draft meeting minutes, the VDD will try to review the minutes and provide a set of consolidated comments or accept the draft meeting minutes within 3 weeks. VDD attendees will need to accept the official record of the minutes.

Sponsors should include accepted pre-submission meeting minutes with the relevant future submission(s), with a rationale for deviation, when applicable.

Submission life cycle

Initial processing of submissions

Once a submission is administratively complete, the VDD will assign it a submission number. The VDD will send an acknowledgement of receipt to the sponsors for these submission types: NDS, ANDS, SNDS, SANDS, NC, DIN and ESC, including responses to notices of non-compliance (NON) as applicable. The VDD does not provide an acknowledgment of receipt for responses to clarification requests, screening deficiency notices (SDNs) or notices of deficiency (NODs).

The VDD will issue a screening acceptance letter for administrative NDSs and protocol reviews once the submission is administratively complete.

Submission screening

All submissions and related information (including responses to screening and review decision letters such as NODs) are subject to screening before being accepted for review. The purpose of screening is to ensure that submissions are prepared in an acceptable format and contain sufficient information to enable a proper review. The VDD also screens the submissions to ensure the sponsor has filed the correct submission type for the changes proposed, that is, it is not beyond the scope of the classification of the submission.

Submission sponsors should ensure that all relevant data is present at the time of filing or is available when the VDD requests it.

Deficiencies at screening

During the screening cycle, if the VDD finds the submission deficient, the VDD will send a clarification request or a screening deficiency notice (SDN) to the sponsor, seeking the outstanding information.

Clarification requests

The VDD may send clarification requests to the sponsor requesting further information or clarification that would enable the completion of screening. The information requested should be readily available as a clarification request wouldn't allow sufficient time for the sponsor to generate new data. The SKMD will send all clarification requests via e-mail.

The sponsor should send responses to clarification requests to the SKMD via email (see Appendix B for contact information). Upon receipt of a clarification request, the sponsor needs to provide a complete response to the VDD within the deadline indicated in the clarification request. The VDD will determine the deadline for response based on the extent and nature of the outstanding items, and will allow a reasonable timeframe for response. The sponsor may request extensions to clarification requests. The VDD will assess these requests on a case-by-case basis. If the VDD cannot accommodate the requested extension within the screening performance target, the VDD may consider putting the submission on inactive status pending a complete response. The VDD would then reset the screening clock upon receipt of a complete response.

Screening deficiency notice (SDN)

A sponsor's failure to respond to a clarification request will result in the issues, or remaining issues, contained in the clarification request being addressed through a SDN.

The VDD will primarily base a decision to issue a SDN on conditions including:

Following the receipt of a SDN, the sponsor needs to provide a complete response within the time specified on the SDN to address the deficiencies.

A new screening period will begin following the receipt of a response to a SDN. The VDD will only issue 1 SDN per screening cycle. If the VDD has already issued a SDN, it will issue a screening rejection notice (SRN) instead to address the remaining issues.

Screening decision

Upon the completion of screening, including the VDD's review of any responses to clarification requests or SDNs, the VDD will proceed with 1 of the 2 screening decisions:

Issuance of a screening acceptance letter

The VDD will base its decision to issue a screening acceptance letter on whether the submission is administratively complete and contains sufficient information to support the acceptance of the submission into review. At this point, the VDD will forward the submission to the relevant review division(s) and enter the first review cycle.

Issuance of screening rejection notice (SRN)

The VDD will base its decision to issue a SRN on conditions including whether:

Submission review period

Once the VDD has screened the submission and found it acceptable, the VDD will forward it to the relevant division(s) for review. The VDD will try to issue a decision letter within the performance targets outlined in Appendix A. The VDD will base the decision letter for the submission on the review outcomes from all relevant review divisions in Table 1.

Table 1. VDD review divisions and areas of focus
VDD Review division Review focus
Clinical Evaluation Division (CED)
  • Animal safety and efficacy and pharmacovigilance
  • Labelling
Quality Evaluation Division (QED)
  • Chemistry, manufacturing and controls
  • Labelling
Human Safety Division (HSD)
  • Human safety: toxicology, residue, microbiological safety
  • Labelling
Submission and Knowledge Management Division (SKMD)
  • Labelling (for review of administrative submissions only)

Communications during the review and clarification requests

The assigned reviewer(s) in each of the appropriate review divisions will review the data submitted. During the course of the review, the VDD may send clarification requests to the sponsor requesting further information or clarification that would help complete 1 or more review streams. A sponsor's failure to provide the information requested, in whole or in part, may affect the VDD's decision and could result in a negative decision letter (for example, notice of deficiency [NOD], notice of non-compliance [NON], refusal letter).

The regulatory project manager (RPM) will send all clarification requests by e-mail only, except administrative new drug submissions, which will be sent via the SKMD generic e-mail account. The information requested should be readily available. A clarification request would not allow sufficient time for the sponsor to generate new data.

Upon receipt of a clarification request, the sponsor needs to provide a complete response to the VDD within the deadline indicated in the clarification request.

The VDD will establish the response times for clarification requests based on the nature of the issues identified, per Table 2: Clarification request timelines.

Table 2: Clarification request timelines
Response time Examples
5 calendar days or less for minor issues Typographical errors, minor clarifications, or minor revisions to documents that can reasonably be expected to be addressed within a short turnaround time
6 to 15 calendar days for all other issues Safety/efficacy/quality clarifications, multiple minor issues in one clarification request, request for data that is known to be accessible to the sponsor (for example, bibliographical data), rationales or expert opinions, missing study information, initial request for complete labelling, PSUR requests

The VDD may also establish response times to accommodate specific circumstances, on a case-by-case basis, and with mutual agreement with the sponsor, as applicable.

The sponsor may request extensions to clarification requests. The VDD will assess these requests on a case-by-case basis. Refer to the pause-the-clock section for more information. The sponsor should address the response to the contact person(s) indicated in the clarification request.

Pause-the-clock during the scientific review

Pause-the-clock is a tool that allows the review clock to be paused 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 review clock can pause only during the review period (for example, first review cycle and second review cycle) for cost-recovered submissions/applications. This mechanism excludes:

A sponsor may request an extension to respond to a clarification request. The sponsor should submit the extension request as soon as possible in the form of a letter and written rationale.

The clock would pause if certain criteria are met:

Following VDD's approval of the extension and after the standard clarification response time has elapsed, the review clock pauses. The sponsor has the additional time approved by Health Canada to respond to the request, and the target date is changed. Note that there may be situations where Health Canada would not approve an extension or grant an extension to an existing pause. The review clock would resume at the end of the approved extension period. If the response to a clarification request is not satisfactory or not submitted within the specified time to respond, a negative decision letter may be issued (this includes interim negative decision letters such as notices of deficiency).

VDD decisions

Once the VDD completes the review of the submission, it may issue different types of decisions, depending on the type of submission and outcome of the review.

For NDS, ANDS, SNDS, SANDS and administrative submissions

The VDD will issue a notice of compliance (NOC) if the submission complies with the regulations after a complete review of the submission by all relevant review divisions.

The VDD will issue a notice of deficiency (NOD) if it identifies outstanding deficiencies and/or significant omissions that preclude continuing the review. Deficiencies identified to date from all relevant review divisions will be included in the NOD. The sponsor needs to provide a complete response to the NOD within a specified deadline (see Appendix A). The VDD will only issue 1 NOD per submission.

The VDD will issue a notice of non-compliance (NON) if:

The VDD will include a rationale as to why the submission is considered not compliant along with a list of the specific deficiencies upon which the decision is based. The VDD will only issue 1 NON per submission.

Upon receipt of a NON, the sponsor may choose to refile the submission at a future time. The VDD will consider the refiled submission as a new submission. The sponsor should follow the instructions outlined in the refiled submission section of this document prior to refiling.

If the sponsor would like to request a reconsideration following receipt of a NON, they may contact the SKMD at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

Other submission types and decisions

After a complete review of the submission by all relevant review divisions, the VDD may issue:

Additional points to consider

Upon the receipt of a SDN, clarification request or NOD, the sponsor must respond within the time specified. If the sponsor cannot provide a response in the time specified, the sponsor may elect to withdraw the submission in place of receiving a subsequent negative decision. The sponsor should refer to the Guidance Document - Fees for the Review of Veterinary Drug Submissions and Applications when refiling a submission.

The sponsor should prepare all responses in a question and answer format with appropriate references to relevant sections of the original submission or information submitted previously. The sponsor must provide a detailed scientific explanation in the absence of the requested information.

The sponsor is encouraged to contact the designated person listed in the correspondence for clarification, when required.

Administrative amendments to submissions under review

At any time, the sponsors may provide administrative updates to submissions under review for changes to:

As part of the update, the sponsor needs to submit:

Post-approval obligations

Administrative submissions

The sponsor must file an administrative submission when there is a(n):

Prior to filing, the sponsor should ensure that the products have a clear registration record (for example, no outstanding issues/submissions that are still under review). To facilitate the review and approval process, the sponsor should limit the data provided to administrative content. Sponsors should file scientific updates under NC, SNDS, SANDS and change to DIN submissions.

The submission process for administrative submissions will be subject to the same management principles, procedures and processes outlined in previous sections of this document.

Transfer of business product lines

In the veterinary drug industry, one company may sell its entire business product line to another company through a commercial purchase transaction. To ensure regulatory compliance, both parties should consider the following points prior to, or even after, the completion of a business transfer:

Changes to a company's address and/or contact name

When there is a change in the company's address and/or contact name, the company needs to submit a letter to the Office of Submissions and Intellectual property (OSIP) at osip-bppi@hc-sc.gc.ca. The letter should state the nature of the changes and provide a list of affected products. The company can be a manufacturer, importer or any manufacturing site that holds an establishment license.

If the address change is related to the manufacturer, importer and/or distributor that is included on the labelling, revised labelling should also be submitted to VDD, along with an updated drug submission application form (DSAF) only for those submissions that are currently under review.

Cancelling a submission prior to approval

A sponsor may cancel a submission at any time. There may be implications for the fees payable depending on the timing of the cancellation. Please consult Guidance Document - Fees for the Review of Veterinary Drug Submissions and Applications for further information.

Refiled submission

A sponsor may refile a submission that was previously withdrawn, rejected, refused or for which a NON was issued.

The VDD will process all refiled submissions as new submissions and assign new submission numbers. They are subject to processing, screening and review as per this document. The refiled submissions are subject to the submission evaluation fees that are in place at the time of refiling.

A refiled submission is subject to any new policies, guidelines and procedures that may be in effect at the time of refiling.

Regardless of whether the related original submission was withdrawn, rejected or refused,, the sponsor must submit a complete set of information as required for all new submissions. It is not acceptable to:

Exceptions may apply in cases where an NON has been issued. If the submission is related to a NON issued for a previously filed NDS, ANDS, SNDS or SANDS submission, data requirements are dependent on when the refiled submission is submitted. Refer to Table 3 for more information.

Table 3. Timing of refiling of a submission
Timing of refiling Data requirement Cross-reference to the original submission?
< 3 years from the date of NON
  • Question and answer format to address deficiencies noted in NON
  • Submission certification that the information submitted in the original submission remains unchanged and is up-to-date (alternatively, the sponsors should provide a summary of the differences between the original submission and the refiled submission)
  • Drug submission application form
Yes
> 3 years from the date of NON
  • Re-submit a complete set of information as required for all new submissions
No

Screening of unsolicited amendments to submission under review

The VDD does not accept unsolicited amendments to submissions already accepted for review unless the amendments meet certain criteria:

When submitting unsolicited amendments to submissions under review, the sponsor must integrate the amended information into the original submission and provide revised copies of the product labels and other affected documents as applicable.

The sponsor should direct all inquiries regarding submission review status to the RPM assigned to the submission, if known. Otherwise, the sponsor can direct these inquiries to the SKMD via e-mail.

The RPM will try to provide a response within 3 working days to inform the sponsor regarding the review progress in the relevant review division(s).

The VDD will only respond to submission status inquiries for sponsors whose names are listed on the DSAF of the submission or to someone who is an authorized agent representing the submission sponsor. The VDD will not disclose any information in response to inquiries from third parties.

The sponsor should send all other inquiries via e-mail to the SKMD. This centralized procedure helps coordinate, track and respond to the high volume of inquiries from submission sponsors.

Drug submission evaluation fees

Prior to filing a submission, the sponsor should consult the fee-related documents to ensure they are using the appropriate fee assessment and following the applicable procedures.

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