Language selection

Government of Canada / Gouvernement du Canada

Search

Veterinary drugs: Management of regulatory submissions: Updated guidance for industry

This updated guidance for industry is under consultation.

On this page

  1. Introduction
  2. An overview of regulatory submission types for veterinary drugs
  3. Procedure for sending regulatory submissions and related information
  4. Submission holds
  5. Pre-submission phase
  6. Submission life cycle
  7. Administrative amendments to submissions under review
  8. Post-approval obligations
  9. Cancelling a submission prior to approval
  10. Refiled submission
  11. Screening of unsolicited amendments to submission under review
  12. Access to submission-related information
  13. Drug submission evaluation fees

1. Introduction

1.1 Purpose

The purpose of this guidance is to inform sponsors about the process that the Veterinary Drugs Directorate (VDD) of Health Canada follows for managing regulatory submissions and related information filed by submission applicants (referred to as sponsors hereafter). This process is in accordance with the Food and Drugs Act and the Food and Drug Regulations where all drugs, unless specifically exempted, must be authorized before being sold or imported for sale in Canada. The VDD is the regulatory authority for the administration of the Food and Drugs Act and Regulations in connection with the sale of drugs intended for use in animals.

This document also provides guidance to sponsors on how to comply with the Food and Drugs Act and Regulations and VDD's policies.

1.2 Scope and application

This guidance applies to the following veterinary submission types:

Please contact the Submission and Knowledge Management Division (SKMD) at hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca for further guidance on Protocol Reviews.

Processes to notify a Veterinary Health Product (VHP) or to seek access to a veterinary drug through the Emergency Drug Release (EDR) program are not within the scope of this document. For information about our VHP Notification program, please contact hc.vhp-psa.sc@canada.ca. For information about the EDR program, please contact hc.edr-dmu.sc@canada.ca.

Submissions filed under joint review or simultaneous review initiatives with other regulatory jurisdictions (e.g. Regulatory Cooperation Council [RCC] initiative with the U.S. Food and Drug Administration's Center for Veterinary Medicine) may be subject to provisions outside of this guidance document. Contact the VDD for submissions filed under joint or simultaneous reviews at hc.vdd.vetdrugs-medsvet.dmv.sc@canada.ca.

For each of the submission types listed above, this guidance outlines the process for the following stages of the submission review and approval process:

During each stage of the submission review and approval process the same submission management principles will be applied and the related decisions are to be made within the VDD's performance targets (see Appendix A).

Information regarding the following regulatory activities is included:

In summary, this is an administrative procedural document. Sponsors should consult the Food and Drugs Act and Regulations as well as applicable Health Canada policies and scientific guidance documents to ensure that all required data components are included at the time of filing.

2. An overview of regulatory submission types for veterinary drugs

2.1 Request for authorization to sell a drug that does not have a DIN

A researcher may seek authorization to permit the sale of a drug without a DIN as part of a veterinary drug study, such as preliminary research, or to generate data to support a veterinary drug regulatory submission in Canada.

A drug without a DIN may be sold when one of the following submissions are filed and a written authorization is obtained from the VDD:

2.2 Request for marketing authorization

A drug must have a valid DIN in order for it to be sold or imported for sale (referred to as sold thereafter) in Canada. The sponsor can, depending on the drug in question, submit one of the following regulatory submissions to the VDD for their request to obtain a DIN for selling a veterinary drug in Canada:       

2.3 Post-approval authorizations: Scientific amendments to initial marketing authorization

2.3.1 Filing updated information

After a sponsor has received a marketing authorization for a new drug, the sponsor is required to file certain updated information or changes to the new drug prior to implementation. Depending on the nature of the changes made, the sponsor is required to file one of the following submission types:

If a sponsor is seeking to make a change to the marketing authorization for a drug that is not a “new drug”, the sponsor is required to file a:

2.3.2 Reactivation of a cancelled DIN by Health Canada

The DIN for a drug can be cancelled either by Health Canada or by the DIN holder in accordance with Section C.01.014.6 of the Food and Drug Regulations.

Once a DIN has been cancelled, the sponsor is required to submit a new submission in order to re-gain marketing approval for a product.  Cross references to previously filed information may be permitted.  However, additional information may also be required by the VDD to ensure that the submission complies with the current regulations and guidelines.

3. Procedure for sending regulatory submissions and related information

All submissions should be sent to the VDD in electronic-only format as per Guidance Document: Preparation of Drug Regulatory Activities in the Non-eCTD Electronic-Only Format. E-mail may be used if the file size is less than 20 MB. 

Use of the Regulatory Enrolment Process (REP), which allows the filing of submissions via the Common Electronic Submission Gateway (CESG), is strongly encouraged for submissions that are within scope of REP.

Sponsors wishing to file via REP can consult the REP guidance documents or e-mail hc.eReview.sc@canada.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 hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca.

4. 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).

4.1 During initial processing

If the information received in a submission does not meet all applicable administrative requirements, the submission will be placed on process hold (e.g. did not follow non-eCTD electronic only format, file path name is too long, forms are missing or not signed). The VDD will send an e-mail to the sponsor to explain the reason(s) for the process hold and request that the sponsor provide a response within a specified number of calendar days. The submission may be rejected if a response is not provided 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.

4.2 During screening, review and the Notice of Compliance (NOC) and/or DIN issuance stage

A submission may be placed on hold in certain situations that prevent further review or issuance of a decision. Situations may include but are not limited to:

5. Pre-submission phase

5.1 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.

5.2 Classification

Where the sponsor needs guidance on the classification of their product, for example, whether it would be regulated as a new drug, not new drug, VHP, feed, or pesticide, etc., the sponsor should send a request for product classification to the VDD at the following e-mail address: hc.classification.vet.sc@canada.ca.

For inquiries related to submission classification (e.g. SNDS vs. NC), the sponsor may send a request for regulatory guidance to the VDD via e-mail. Adequate information should be provided 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 chemistry and manufacturing, target animal safety and efficacy and human safety aspects of the drug product.

The VDD will provide guidance based on the information provided by the sponsor. Verification of the submission classification will be done based on the actual information provided at the time of the submission filing. The submission may be re-classified if it contains additional changes or if the overall changes are considered beyond the scope of the current classification.

5.3 Pre-submission meeting

5.3.1 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 frame when planning to request a pre-submission meeting with the VDD.

The meeting request should be sent to the VDD by e-mail using the Pre-Submission Meeting Request template located on our Forms - Applications and submissions - Veterinary Drugs website.

Adequate product-related information should be provided to enable the review divisions to assess the meeting request and to select appropriate meeting attendees from the VDD. The meeting request will be logged in and assigned a submission number. 

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

5.3.2 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 that the information submitted is sufficient to allow the appropriate feedback from the VDD. It is recommended that the package be limited to 40 pages in length and it should contain the following information:

5.3.3 Following the pre-submission meeting

Once the pre-submission meeting is held, the sponsor is requested to provide the VDD with a draft copy of the minutes of the meeting via e-mail within two weeks. The meeting minutes should consist of, but not be limited to, the following elements:

Upon receipt of the draft meeting minutes, the VDD will target to review the minutes and provide a set of consolidated comments or accept the draft meeting minutes within three weeks. The official record of the minutes will require acceptance by the VDD attendees.

Accepted pre-submission meeting minutes should be included with the relevant future submission(s), with a rationale for deviation, when applicable.

6. Submission life cycle

6.1 Initial processing of submissions

Once a submission is administratively complete, it will be assigned a submission number. An acknowledgement of receipt will be sent to the sponsors for the following submission types: NDS, ANDS, SNDS, SANDS, NC, DIN, and ESC, including responses to Notices of Non-Compliance (NON) as applicable. An acknowledgment of receipt is not provided for responses to Clarification Requests, Screening Deficiency Notices (SDNs) or Notices of Deficiency (NODs).

For Administrative NDSs and Protocol Reviews, a Screening Acceptance Letter will be issued once the submission is administratively complete.

6.2 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 submissions are also screened to ensure that the correct submission type has been filed for the changes proposed, i.e., that 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 data is requested by the VDD.

6.3 Deficiencies at screening

During the screening cycle, if the submission is found to be deficient, a Clarification Request or a Screening Deficiency Notice (SDN) is sent to the sponsor, seeking the outstanding information.

6.3.1 Clarification Requests 

Clarification Requests may be sent to the sponsor requesting further information or clarification that would enable the completion of screening. All Clarification Requests will be sent by e-mail only and will be sent by the SKMD.

Responses to Clarification Requests should be sent to the SKMD via email (see Appendix B for contact information). Upon receipt of a Clarification Request, the sponsor is required to provide a complete response to the VDD within the deadline indicated in the Clarification Request. The deadline for response will be determined based on the extent and nature of the outstanding items, and a reasonable timeframe for response will be given. Extensions to Clarification Requests may be requested and will be assessed on a case-by-case basis.  If the requested extension cannot be accommodated within the screening performance target, the VDD may consider putting the submission on inactive status pending a complete response. The screening clock would then be reset upon receipt of a complete response.

6.3.2 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.

A decision to issue a SDN will be primarily based on, but not be limited to, the following conditions:

Following the receipt of a SDN, the sponsor is required 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. Only one SDN may be issued per screening cycle. If an SDN has already been issued, a Screening Rejection Notice (SRN) will be issued instead to address the remaining issues.

6.4 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 one of the following two screening decisions:

6.4.1 Issuance of a Screening Acceptance Letter

A decision to issue a Screening Acceptance Letter will be based on the screening decision that the submission is administratively complete and contains sufficient information to support the acceptance of the submission into review, at which point it will be forwarded to the relevant review division(s) and enter the 1st Review Cycle.

6.4.2 Issuance of a Screening Rejection Notice (SRN)

A decision to issue a SRN will be made based on, but not be limited to, the following conditions: 

6.5 Submission review period

Once the submission is screened and found acceptable, it is forwarded to the relevant division(s) for review. The VDD will target to issue a decision letter within the VDD's target performance standards outlined in Appendix A. The decision letter for the submission will be based 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)

6.5.1 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, Clarification Requests may be sent to the sponsor requesting further information or clarification that would facilitate the completion of one 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 (e.g. Notice of Deficiency [NOD], Notice of Non-compliance [NON], Refusal Letter).

All Clarification Requests will be sent by e-mail only and will be sent by the Regulatory Project Manager (RPM) except for Administrative New Drug Submissions, which will be sent via the SKMD generic e-mail account. A Clarification Request will only be used to request further clarification to facilitate the relevant division(s)'s review of a submission. 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 is required to provide a complete response to the VDD within the deadline indicated in the Clarification Request. 

Response times for Clarification Requests will be established based on the nature of the issues identified, as per the table below.

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 (e.g. 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.

Extensions to Clarification Requests may be requested and will be assessed on a case-by-case basis. Refer also to Section 6.5.2 below regarding Pause-the-Clock.  The response should be addressed to the contact person(s) indicated in the Clarification Request.

6.5.2 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 (e.g. 1st Review Cycle and 2nd Review Cycle) for cost-recovered submissions/applications. Administrative submissions/applications are excluded from this mechanism as well as parallel or joint reviews with other regulatory authorities.

A sponsor may request an extension to respond to a Clarification Request. The extension request should be submitted as soon as possible in the form of a letter and written rationale.

The clock would pause if the following criteria are met:

Following Health Canada'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.

6.6 VDD decisions

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

6.6.1 For NDS, ANDS, SNDS, SANDS and Administrative submissions

A Notice of Compliance (NOC) will be issued if the submission is found to be in compliance with the Regulations after a complete review of the submission by all relevant review divisions. 

A Notice of Deficiency (NOD) will be issued where outstanding deficiencies and/or significant omissions that preclude continuing the review are identified. Deficiencies identified to date from all relevant review divisions will be included in the NOD. The sponsor is required to provide a complete response to the NOD within a specified deadline (see Appendix A). Only one NOD will be issued per submission.

A Notice of Non-Compliance (NON) will be issued if a sponsor fails to provide a complete response to a NOD within the specified deadline, or following a complete review of the response to a NOD by the relevant review divisions, the submission remains deficient. 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. Only one NON will be issued per submission.

Upon receipt of a NON, the sponsor may choose to refile the submission at a future time. The refiled submission will be considered as a new submission. The sponsor should follow the instructions outlined in Section 10 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 hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca.

6.6.2 Other submission types and decisions

After a complete review of the submission by all relevant review divisions, the following decisions may be issued.

6.7 Additional points to consider

Upon the receipt of a SDN, Clarification Request or NOD, the sponsor must respond within the time specified. If a response cannot be provided 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  if and when refiling a submission.

All responses should be prepared in a question and answer format with appropriate references to relevant sections of the original submission or information submitted previously. A detailed scientific explanation must be provided in the absence of the requested information.

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

7. Administrative amendments to submissions under review

The submission sponsors may at any time provide administrative updates to submissions under review regarding a change for any of the following:

As part of the update, the sponsor is required to submit the following:

8. Post-approval obligations

8.1 Administrative submissions

An administrative submission must be filed when there is a change in the name of the manufacturer, change in product ownership, merger/buyout, additional product name or licensing agreement between two manufacturers (DIN, NDS, or ANDS submission) or a change in the product name (DIN, SNDS, SANDS submission).

Prior to filing, the sponsor should ensure that the products have a clear registration record (e.g. no outstanding issues/submissions that are still under review). To facilitate the review and approval process, data provided for the administrative submissions should be limited to administrative content. Scientific updates should be filed 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.

8.2 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, consideration should be given to the following points prior to, or even after, the completion of a business transfer:

8.3 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 is required to submit a letter to the Office of Submissions and Intellectual property (OSIP) at hc.osip-bppi.sc@canada.ca stating the nature of the changes and provide a list of products that are being affected by the change. The company referred to here 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.

9. 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.

10. Refiled submission

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

All refiled submissions will be processed as new submissions and assigned 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 rejected, refused or withdrawn, the sponsor must submit a complete set of information as required for all new submissions. Cross-references to previously submitted information in lieu of resubmitting the information or cross-reference to a submission that has not received a positive clearance (e.g. NOC, ISL or a NOL) is not acceptable.  Exceptions may apply in cases where an NON has been issued.  Please refer to the paragraph below and Table 3.

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.

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

11. Screening of unsolicited amendments to submission under review

The VDD does not accept unsolicited amendments to submissions that have been accepted for review unless the amendments meet the following criteria:

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

12. Access to submission-related information

All inquiries regarding submission review status should be directed to the RPM assigned to the submission, if known; otherwise, these inquiries can be directed to the SKMD via e-mail.

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

It should be noted, however, that 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. No information can be disclosed in response to inquiries from other third parties.

All other inquiries should be sent via e-mail to the SKMD. This centralized procedure is to better coordinate, track and respond to the high volume of inquiries from submission sponsors. 

13. Drug submission evaluation fees

Prior to filing a submission, the sponsor should consult the following documents to ensure appropriate fee assessment is carried out and the applicable procedures are followed.

Appendix A: Performance targets for veterinary drug submissions

Activity Type Submission Type Performance Target in Calendar Days (VDD) Performance Target in Calendar Days (Sponsor) Comments

Pre-submission meeting request

Pre-Submission
(NDS, ANDS, SNDS, SANDS, IND, NC, DIN, ESC, Protocol Review)

Not applicable

At least 60 prior to the proposed meeting date

Not applicable

Pre-submission meeting package

Pre-Submission
(NDS, ANDS, SNDS, SANDS, IND, NC, DIN, ESC, Protocol Review)

Not applicable

As specified by VDD in meeting confirmation

Not applicable

Draft pre-submission meeting minutes

Pre-Submission
(NDS, ANDS, SNDS, SANDS, IND, NC, DIN, ESC, Protocol Review)

Not applicable

14

 Not applicable

Review of draft pre-submission meeting minutes

Pre-Submission
(NDS, ANDS, SNDS, SANDS, IND, NC, DIN, ESC, Protocol Review)

21

Not applicable

Not applicable

Screening

NDS, ANDS, SNDS, SANDS

45

Not applicable

INDs and Protocol Reviews are verified for administrative completeness only

NC, DIN, Change to DIN, Administrative submissions

14

ESC/ ESC Amendment

7

IND, Protocol Review

Not applicable

Issuance of SDN

NDS, ANDS, SNDS, SANDS, Administrative new drug submissions, Protocol Review, DIN, Administrative DIN, Change to DIN

Not applicable

45

Once administratively complete, deficiencies for Administrative submissions will be addressed during review.

Protocol Reviews will not be scientifically screened and will either be accepted for review once administratively complete or rejected if the submission does not qualify as a Protocol Review.

NC, ESC, ESC Amendment

Not applicable

30

Screening of response to SDN

NDS, ANDS, SNDS, SANDS, NC, DIN

14

Not applicable

 Not applicable

ESC

7

Issuance Screening Acceptance Letter

NDS, ANDS, SNDS, SANDS, Administrative new drug submissions, Protocol Review, DIN, Administrative DIN, Change to DIN, NC, ESC, ESC Amendment

Not applicable

Not applicable

 Not applicable

Issuance of SRN

NDS, ANDS, SNDS, SANDS, Administrative new drug submissions, Protocol Review, DIN, Administrative DIN, Change to DIN, NC, ESC, ESC Amendment

Not applicable

Not applicable

If the sponsor decides to refile this submission at a future time, it will processed as a new submission.

Issuance of Clarification Request

NDS, ANDS, SNDS, SANDS, Administrative new drug submissions, IND, Protocol Review, DIN, Administrative DIN, Change to DIN, NC, ESC, ESC Amendment

Not applicable

As indicated in Clarification Request

 Not applicable

Issuance NOD

NDS, ANDS, SNDS, SANDS, Administrative new drug submissions, DIN, Administrative DIN, Change to DIN

Not applicable

90

 Not applicable

NC, ESC, ESC Amendment, Protocol Review

Not applicable

30

Screening of response to NOD

NDS, ANDS, SNDS, SANDS, Administrative new drug submissions,  DIN, Administrative DIN, Change to DIN, NC, ESC, ESC Amendment

Same as for initial submission

Not applicable

 Not applicable

Review of initial submission

NDS, ANDS

300

Not applicable

 Not applicable

SNDS, SANDS

240

NC

90 (or 120 for 120-day NCs)

Administrative NDS/ANDS/SNDS/SANDS

90

Protocol Review, ESC/ ESC Amendment, IND/IND Amendment

60

DIN/Administrative DIN/Change to DIN

120

Review of response to NOD (2nd review cycle)

NDS, ANDS

150

Not applicable

 Not applicable

SNDS, SANDS

120

DIN, Administrative DIN, Change to DIN, NC, ESC, ESC Amendment, Protocol Review

60

Administrative NDS/ANDS and  Administrative SNDS/SANDS

45

Appendix B: Contact information

Subject Contact Address
All submission-related documents and requests except for product classification requests E-mail: hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca
Product classification requests E-mail: hc.classification.vet.sc@canada.ca
Regulatory Enrolment Process (REP) E-mail: hc.eReview.sc@canada.ca  

Appendix C: Definitions

Administrative submissions:
a submission that does not require scientific review. Includes NDS, ANDS, SNDS, SANDS, NC submission types.
Amendment to an ESC:
the request to amend an approved ESC, e.g. require more drug product; change in study location; change in investigator.
Drug Identification Number (DIN):
an 8-digit numerical code assigned to each drug product.
Experimental Studies Certificate (ESC) Submission:
information and material to support the issuance of an Experimental Studies Certificate for a drug to be administered to either a food or non-food producing animal.
Investigational New Drug (IND) submission:
a preclinical submission filed pursuant to Section C.08.005 of the Food and Drug Regulations.
Manufacturer:
company to whom the DIN number was assigned to for a given drug product.
Protocol Review:
the request for the review of scientific information outside of a regular drug submission (i.e. review of a proposed trial protocol).
Review:
the period from the time a submission is accepted for review to the time when a decision is made on that submission.
Screening:
the period from the time an administratively complete submission is received in the VDD to the time when a screening decision is made on that submission (also referred to as preliminary examination).
Sponsor:
the applicant who filed a drug submission with the VDD.
1st Review Cycle:
the period during which the original submission is under review.
2nd Review Cycle:
the period during which the response to a Notice of Deficiency is under review.

Page details

Date modified: