ARCHIVED - Guidance Document: Reconsideration of Decisions Issued for Veterinary Drug Submissions

Date: 2009/06/18

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations. They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.

Table of Contents


1 Policy Objectives

To ensure that disputes that arise with respect to veterinary drug submissions are resolved effectively, efficiently, and in accordance with the Health Products and Food Branch (HPFB) Guiding Principles on Dispute Resolution (available on the Health Canada website).

2 Scope and Application

This document applies to disputes arising between Health Canada and veterinary drug submission sponsors over Screening Rejection Notice (SRN) and Notice of Non-compliance (NON) decisions issued for one of the following veterinary drug submission types:

  • New Drug Submission (NDS);
  • Administrative NDS including submissions filed in support of corporate and brand name changes;
  • Supplemental New Drug Submission (SNDS);
  • Abbreviated New Drug Submission (ANDS);
  • Supplemental Abbreviated New Drug Submission (SANDS); or
  • Notifiable Change (NC).

This guidance document applies to all sponsors of veterinary drug submissions, and to all Veterinary Drugs Directorate (VDD) staff involved in the drug submission and Reconsideration process.

This document supercedes the Health Canada policy: Blueprint for the Veterinary Drug Submission Appeal Process, which came into effect June 19, 2003.

3 Policy Statements

The Reconsideration process is a formal dispute resolution process and is intended to be initiated when informal mechanisms have failed to resolve the issue(s). Refer to Appendix 1 for a map of the Reconsideration process.

Appendix 2 outlines performance targets for each step of the process, for various submission and decision types. VDD will make every effort to expedite those processes and steps that are within its control; in addition, the sponsor may request that an expedited process be followed as outlined in Section 5.3.1(c).

Following the issuance of a decision (Section 5.1), sponsors may file a Request for Reconsideration. A Letter of Intent must be filed within 30 calendar days of the date of the decision under dispute, clearly stating the sponsor's intention to commence the Reconsideration process (Section 5.1.1).

It is the sponsor's choice to initiate and participate in the Reconsideration process. The sponsor is able to withdraw from the Reconsideration process at any point. If, at any time during the Reconsideration process, the sponsor files a Notice of Application to the Federal Court to resolve the matter, VDD will terminate the Reconsideration process.

Within 45 calendar days of the date of the acknowledgement of the Letter of Intent, the sponsor must submit a Request for Reconsideration to the Director General (Section 5.1.2). The Request for Reconsideration should be a brief, high-level summary of the issue(s) in dispute, and should not introduce new issues (Section 5.2).

The information filed will be assessed for relevance to the issue(s) under dispute. The Reconsideration process is not an opportunity to add to the content of the original submission, or to circumvent established processes for refiling submissions. As such, new studies will not be accepted as part of the Request for Reconsideration (Section 5.2.1).

The sponsor and the review division(s) will have the opportunity to present their positions on the issues under dispute to the Director General, who will make the Reconsideration decision. To assist with the resolution of a Request for Reconsideration, VDD may refer one or more issues under dispute to an external panel for advice (either an existing Scientific Advisory Committee or a Reconsideration Panel). Other issues may not be appropriate for referral to an external panel and may be reviewed internally (Section 5.3).

The Reconsideration decision will be issued by the Director General. For each issue under dispute, the Director General may uphold or amend his/her original position, or refer the issue back to the review division(s) for re-evaluation and preparation of a new decision letter reflecting the re-evaluation of the issue under dispute (Section 5.4).

Reconsideration decisions will be disseminated externally via a Summary Basis of Reconsideration decision to be posted on the Health Canada web site. The document will be a factual document summarizing VDD's position on a particular issue, and will not contain proprietary or identifying information about the drug or the sponsor (Section 5.7).

4 Roles and Responsibilities

The following bullets outline the major responsibilities of each partner in the formal Reconsideration process.

Director General

The Director General of VDD or his/her designate is responsible for:

  • refusing Reconsiderations filed for decisions that are not eligible;
  • deciding whether to consider information filed in the Request for Reconsideration;
  • deciding on the process for the disposition of the Request for Reconsideration;
  • deciding on the use and membership of the Scientific Advisory Committee or Reconsideration Panel (if applicable); and
  • making the Reconsideration decision.

Veterinary Drug Submission Sponsor

The veterinary drug submission sponsor is responsible for:

  • filing a Letter of Intent (two copies) and a Request for Reconsideration (two copies) for eligible decisions;
  • ensuring the Request for Reconsideration package is complete;
  • providing nomination(s) for one member of a Reconsideration Panel if formed;
  • working with the Policy Regulatory and International Affairs Division to draft questions to be posed to the external panel (Scientific Advisory Committee or Reconsideration Panel) (if applicable); and
  • making a presentation to the Director General, the Policy Regulatory and International Affairs Division, and the Scientific Advisory Committee or Reconsideration Panel (if applicable).

Policy Regulatory and International Affairs Division (PRIAD)

PRIAD of VDD is responsible for:

  • responding to inquiries regarding the Reconsideration process;
  • responding to extension requests related to the Reconsideration process;
  • assessing the relevance of information filed in the Request for Reconsideration, with the input of the Submission & Knowledge Management and the review divisions as needed;
  • reviewing information provided by the sponsor and the review division related to the Reconsideration process;
  • recommending to the Director General a process for the disposition of the Request for Reconsideration;
  • making recommendations to the Director General regarding the membership of the Scientific Advisory Committee or Reconsideration Panel (if applicable);
  • coordinating the Scientific Advisory Committee or Reconsideration Panel and managing its operations (if applicable);
  • consulting with other areas of expertise as needed, and communicating any new considerations to all involved parties;
  • preparing an Issue Analysis Summary with recommendations on the disposition of the Request for Reconsideration;
  • identifying potential policy/guidance issues and referring them to the Director General;
  • identifying potential missed opportunities for dispute prevention and early resolution;
  • disseminating Reconsideration decisions internally in VDD;
  • preparing a Summary Basis of Reconsideration Decision for each Reconsideration decision, and arranging its translation and posting on the Health Canada web site; and
  • forwarding all documents generated during the Reconsideration process to the Submission & Knowledge Management Division for filing.

Submission & Knowledge Management Division (SKMD)

The SKMD of VDD is responsible for:

  • responding to inquiries regarding the Reconsideration process;
  • receiving Letters of Intent and Requests for Reconsideration;
  • determining whether decisions are eligible for Reconsideration when a Letter of Intent is filed;
  • acknowledging receipt of the Letter of Intent if the decision is eligible for Reconsideration;
  • acknowledging receipt of Requests for Reconsideration filed.
  • assisting PRIAD with the assessment of the relevance of information filed in the Request for Reconsideration;
  • ensuring follow-up actions are taken on each submission after the Reconsideration decision has been made;
  • ensuring documents generated during the Reconsideration process are appropriately filed, and tracking is complete; and
  • ensuring Reconsideration decisions, and recommendations for dispute prevention and early resolution are incorporated into the process for future submissions.

Review Division Directors

The Directors of the review divisions of VDD are responsible for:

  • ensuring that review reports and decision letters accurately and completely reflect the division's position on the submission:
  • assisting PRIAD with the assessment of the relevance of information filed in the Request for Reconsideration;
  • providing nomination(s) for one member of a Reconsideration Panel if formed;
  • working with PRIAD to draft questions to be posed to the external panel (Scientific Advisory Committee or Reconsideration Panel) (if applicable);
  • ensuring a presentation is made to the Director General, PRIAD, and the Scientific Advisory Committee or Reconsideration Panel (if applicable);
  • ensuring follow-up actions are taken on each submission after the Reconsideration decision has been made; and
  • ensuring Reconsideration decisions, and recommendations for dispute prevention and early resolution are incorporated into the process for future submissions.

Scientific Advisory Committee / Reconsideration Panel

The Scientific Advisory Committee or Reconsideration Panel is responsible for:

  • making recommendations in answer to specific questions concerning the issue(s) under dispute;
  • identifying potential policy/guidance issues to be referred to the Director General; and
  • identifying potential missed opportunities for dispute prevention and early resolution.

5 Guidance for Implementation

The Reconsideration process is a formal dispute resolution process and is intended to be initiated when informal mechanisms have failed to resolve the issue(s).

It is the sponsor's choice to initiate and participate in the Reconsideration process. The sponsor is able to withdraw from the Reconsideration process at any point. If, at any time during the Reconsideration process, the sponsor files a Notice of Application to the Federal Court to resolve the matter, VDD will terminate the Reconsideration.

Refer to Appendix 1 for a map of the Reconsideration process.

Appendix 2 outlines performance targets for each step of the process, for various submission and decision types. VDD will make every effort to expedite those processes and steps that are within its control; in addition, the sponsor may request that an expedited process be followed as outlined in Section 5.3.1(c).

5.1 Filing of the Request for Reconsideration

Sponsors may file a Request for Reconsideration following the issuance of a Screening Rejection Notice (SRN) or a Notice of Non-compliance (NON) decision issued for one of the following drug submission types:

  • New Drug Submission (NDS);
  • Administrative NDS including submissions filed in support of corporate and brand name changes;
  • Supplemental New Drug Submission (SNDS);
  • Abbreviated New Drug Submission (ANDS);
  • Supplemental Abbreviated New Drug Submission (SANDS);or
  • Notifiable Change (NC).

5.1.1 Letter of Intent

Within 30 calendar days of the date of the decision under dispute, the sponsor must submit a Letter of Intent to the Director General of VDD. The Letter of Intent should clearly state the sponsor's intention to commence the formal Reconsideration process. Two copies of the Letter of Intent should be filed.

The Letter of Intent should be addressed to the Director General and sent to the attention of the Director of SKMD at the address below. Note that sending the document to a location other than SKMD may result in delays.

Director General
c/o Director, Submission & Knowledge Management Division
Veterinary Drugs Directorate
Health Products and Food Branch
Holland Cross Complex
Ground Floor, Suite 14
11 Holland Avenue, A.L. 3000A
OTTAWA, Ontario
K1A 0K9
Fax: (613) 957-3861

The Director of SKMD or his/her designate (hereafter referred to as "the Director of SKMD") will review the Letter of Intent to determine whether the decision under dispute is one for which a Request for Reconsideration can be filed (i.e. whether the decision is one listed in Section 5.1).

If the decision for which the Letter of Intent was filed is eligible for Reconsideration, the Director of SKMD will acknowledge receipt of the Letter of Intent and indicate that the decision is eligible for Reconsideration. The Director of SKMD will forward the Letter of Intent to PRIAD.

If the decision for which the Letter of Intent was filed is not eligible for Reconsideration, the Director of SKMD will ensure the sponsor is contacted and the Reconsideration process and the mechanisms available for dispute resolution are explained. The Reconsideration will be refused by the Director General or his/her designate (hereafter referred to as "the Director General").

5.1.2 Request for Reconsideration

The sponsor must submit a formal Request for Reconsideration addressed to the Director General of VDD within 45 calendar days of the date of the acknowledgement letter sent by the Director of SKMD . Two copies of the Reconsideration package should be filed.

The Request should be addressed to the Director General and sent to the attention of the Director of SKMD at the address given in Section 5.1.1. Note that sending the document to a location other than SKMD may result in delays.

SKMD will acknowledge receipt of the Request and will forward it to PRIAD.

PRIAD may grant requests for extension of the time allowed to file the Request for Reconsideration. Extension requests should be filed in writing to SKMD at the address given in Section 5.1.1, and should include a rationale for the request. The rationale will be evaluated and a decision will be made by PRIAD on a case-by-case basis.

5.2 Format and Content of the Request for Reconsideration

The Request for Reconsideration is expected to be filed in the prescribed format (see template provided in Appendix 3) and contain the following information:

  • a copy of the decision for which Reconsideration is requested;
  • statements, in numbered paragraphs, with the sponsor's definition of the issue(s) of contention, linking closely with the points of the original decision;
  • for each issue identified, the grounds of the dispute in numbered paragraphs;
  • the sponsor's preferred process for resolution of the Request for Reconsideration (i.e. referral of one or more issues to an existing Scientific Advisory Committee or to a newly created Reconsideration Panel, review of one or more issues by PRIAD, or a combination of the two);
  • the name of one or more nominees for a Reconsideration Panel (see below for more information); and
  • whether the sponsor wishes to follow an expedited process, as outlined in Section 5.3.1(c).

Two copies of the Reconsideration package should be filed. If the Reconsideration package is not complete, PRIAD will contact the sponsor to request additional information.

The grounds should be cross-referenced to the information filed in the original submission (and/or the response to a Screening Deficiency Notice or Notice of Deficiency if applicable). The Request for Reconsideration should be a brief, high-level summary of the issue(s) in dispute, and should not introduce new issues. The issues and the grounds should not exceed a total of 20 pages (not including supporting references).

The sponsor is requested to provide nomination(s) for one member of the Reconsideration Panel with expertise relevant to the resolution of the matter. To ensure that nominees can comply with conflict of interest requirements the sponsor should not contact the nominee(s), and should not provide them with any material for review prior to the official appointment of the member by the Director General. The nominees should not have been involved with the sponsor for the product in question and should not have expressed their views regarding the product in question. Refer to section 5.3.1 for more information.

The decision letter and supporting review documents will provide the review division's definition of the issue(s) and grounds. Together, the documents from the sponsor and the review division(s) will form the basis for deliberations by PRIAD, an external panel if consulted, and the Director General.

5.2.1 Relevance of Information Filed

PRIAD, with the input of the Director of SKMD and the review division(s) as needed, will assess all information filed in support of the Request for Reconsideration to determine whether it is relevant to the issue(s) under dispute. The Director General may refuse information filed on the recommendation of PRIAD.

The Reconsideration process is not an opportunity to add to the content of the original submission, or to circumvent the process for refiling submissions as outlined in the Guidance for Industry: Management of Regulatory Submissions (MORS). As such, new studies will not be accepted as part of the Request for Reconsideration.

The decision to refuse information will be communicated in writing by the Director General in the letter issued to the sponsor in Section 5.3.

If information was filed and refused by the Director General, the sponsor may submit this information as part of a refiled submission in accordance with Section 13 of the MORS. The Director of SKMD will ensure the sponsor is contacted to determine whether it wishes the information to be considered in accordance with the MORS. If so, the sponsor will be asked to submit the information as part of a refiled submission, with a new control number and new fees. The sponsor will be asked to inform SKMD in writing whether it wishes the Request for Reconsideration to continue without the new information, or to withdraw the Request and await a decision on the new submission.

Sponsors are discouraged from pursuing both a Reconsideration and a refiled submission on the same issue. As the two processes will not proceed simultaneously; the sponsor will be contacted by SKMD to choose which one should proceed first. The other will continue once the first has been completed.

5.3 Review of the Request for Reconsideration

PRIAD will review the material presented and will recommend a process to be followed for the disposition of the Request. Options include the referral of issues under dispute to an external panel (an existing Scientific Advisory Committee as described in 5.3.1 or a Reconsideration Panel as described in 5.3.1(b)), the review of issues by PRIAD, or a combination of the two. Some issues identified in the Request for Reconsideration may be referred to an external panel, while others within the same Request may be addressed by PRIAD.

Issues that may be appropriate for referral to an external panel include:

  • interpretation of available data;
  • disagreement in applied methodology; and
  • relative weights given to data impacting on the risk/benefit assessment of the submission information.

Issues that generally are not appropriate for referral to an external panel may include those that involve:

  • submission of false information;
  • allegations of bias;
  • matters in which regulatory policy/guidance or procedures are the dominant concern; and
  • an issue on which VDD has available recent external independent expert opinion.

PRIAD will make a recommendation to the Director General on the appropriateness of seeking external advice on one or more issues; the Director General will make a decision and will inform the sponsor by mail. The letter to the sponsor will contain the proposed process for disposition of the Request, including details about the process and rationale for seeking external advice if applicable. If any information filed within the Request is refused as described in Section 5.2.1, this will also be outlined in the letter.

5.3.1 Provision of External Advice

If the Director General decides that it is appropriate to seek external advice, the issues will normally be referred to an existing Scientific Advisory Committee (SAC) with expertise relevant to the issue. PRIAD may choose to convene a sub-set of SAC members with relevant expertise to deal with the issues, or the SAC may be supplemented by ad hoc members if additional expertise is required. In both situations, the sponsor will have the opportunity to participate in choosing the panel members. If a relevant SAC does not exist, a Reconsideration Panel will be formed (see Section 5.3.1(b)). PRIAD is responsible for coordinating the SAC or Reconsideration Panel and managing its operations.

(a) Scientific Advisory Committee Meeting

Consistent with its advisory role, the SAC will not be asked to make a decision on the submission; rather, advice will be solicited through one or more direct questions related to the specific outstanding issue(s) identified. PRIAD will work with the sponsor and the review division(s) to draft specific questions to be posed to the SAC.

PRIAD will ensure that background material is provided to the SAC with enough time for review and consideration.

Formal presentations should be made to the SAC by both the sponsor and the review division representative. PRIAD will set the agenda and allot an appropriate time for each speaker. Each presentation should consist of a brief overview of the salient points of the issue(s) under dispute, and will be followed by a question and answer period. The Director General will be present for both parties' presentations so that both have an opportunity to be heard by the person who will make the Reconsideration decision. In addition, both parties will be present during both presentations and the question and answer periods that follow. The Director General will then leave the SAC to its independent deliberations and discussions of the specific questions to be considered by the SAC on the issues identified.

The Chair of the SAC, will submit a report capturing each question, the discussion, and the agreed-upon response. This version will become the official record of the meeting.

Costs associated with the SAC meeting will be paid by VDD in accordance with Treasury Board guidelines.

(b) Reconsideration Panel

If there is no SAC with expertise relevant to the issue, a Reconsideration Panel will be formed. The membership of the Reconsideration Panel will be determined by the sponsor and by VDD as follows:

  • one member selected by the Director General from nominations by the sponsor;
  • one member selected by the Director General from nominations by the relevant Division Director; and
  • one member appointed by the Director General, who, when possible, is a member of an existing SAC and who will chair the Reconsideration Panel.

As stated in Section 5.2, the sponsor is requested to provide nomination(s) for one member of the Reconsideration Panel with expertise relevant to the resolution of the matter, as an attachment to the Request for Reconsideration. To ensure that nominees can comply with conflict of interest requirements the sponsor should not contact nominees, and should not provide them with any material for review prior to the official appointment of the member by the Director General. The nominees should not have been involved with the sponsor for the product in question and should not have expressed their views regarding the product in question.

Generally, the sponsor's nominee will be accepted by the Director General, unless he/she has an identified conflict. In this situation, the sponsor will be notified by PRIAD and asked to provide another nominee.

PRIAD will solicit nominations for one member of the Reconsideration Panel from the review division Director. PRIAD will review the membership of existing Scientific Advisory Committees and will make a recommendation to the Director General for the chair of the Reconsideration Panel.

PRIAD will contact nominees for their curriculum vitae. Members will be chosen based on their experience, expertise, and/or analytical skills relevant to the review of a particular disputed issue. All Panel members must meet conflict of interest and security clearance requirements. Any person who was involved with decisions related to the submission, or reviewed information related to the submission on behalf of VDD or the sponsor will not be eligible as a member of the Reconsideration Panel. Detailed information on security and conflict of interest requirements is available from PRIAD.

PRIAD will contact nominees provided by the sponsor and the review division and determine whether they are interested and available to participate in the Panel. PRIAD will then make a recommendation to the Director General on the membership of the Panel.

Costs associated with the Panel meeting will be paid by VDD in accordance with Treasury Board guidelines.

The roles and responsibilities of the Panel, and the process for obtaining its advice will be the same as for the SAC outlined in Section 5.3.1(a). Consistent with its advisory role, the Panel will not be asked to make a decision on the submission; rather, advice will be solicited through one or more direct questions related to the specific outstanding issue(s) identified.

(c) Expedited Process

If the sponsor wishes to expedite the process, it may be possible to conduct the SAC or Reconsideration Panel (or PRIAD/Director General) meeting by telephone or video conferencing. The sponsor should indicate in the Request for Reconsideration package whether it wishes to pursue an expedited process if possible.

Options to expedite the process will be presented to the sponsor in the letter from the Director General described in Section 5.3.

5.3.2 Review by Policy Regulatory and International Affairs Division (PRIAD)

As described above, some issues within a Request for Reconsideration may not be appropriate for referral to an external panel. In such cases, it will be reviewed by PRIAD. In the letter issued in Section 5.3, the Director General will extend an invitation to the sponsor to meet to discuss these issues. At this meeting, both the sponsor and the review division(s) representatives will present their positions on the remaining issue(s) to the Director General and PRIAD. The formal presentations will be followed by a question and answer period. The purpose of the meeting will be to provide both parties with an opportunity to be heard by the person who will make the Reconsideration decision. It is intended to be non-confrontational while allowing a full discussion of the issue(s).

Where one or more issues will be referred to an external panel while others in the same Request will be reviewed by PRIAD, the meeting with the Director General will be held on the same day as the meeting of the external panel (SAC or Reconsideration Panel) if possible.

5.3.3 Consultation by Policy Regulatory and International Affairs Division (PRIAD)

PRIAD may consult with areas of expertise within Health Canada as needed throughout its review. For example, PRIAD may discuss regulatory or guidance issues with the Director of SKMD, or Health Canada Legal Services.

If new considerations (for example, new safety information) are raised during this consultation, or at any point during the Reconsideration process, they will be communicated to all involved parties (i.e. sponsor, review division, SAC or Reconsideration Panel, etc.).

5.3.4 Recommendation by Policy Regulatory and International Affairs Division (PRIAD)

PRIAD will prepare an Issue Analysis Summary (IAS) containing the issues, analysis, and recommendations on the disposition of the Request. The IAS will include a summary of the process, information considered in the analysis, and detailed recommendations for follow-up actions to be taken.

PRIAD has several options for the disposition of Requests for Reconsideration. For each issue under dispute, PRIAD can recommend that, upon Reconsideration, the Director General choose one of three options:

  • to uphold his/her original position on the issue;
  • to amend his/her original position on the issue and ask that an amended version of the original decision letter be issued; or
  • in exceptional circumstances, to refer the submission back to the review division for re-evaluation of the issue under dispute and request that a new decision letter be prepared reflecting the re-evaluation of the issue under dispute. The new decision letter would then be eligible for Reconsideration, for that issue only. This would normally be recommended only in exceptional cases where the process was not appropriately applied and/or pertinent information was not appropriately considered.

In addition to its recommendation on the disposition of the Request, the SAC or Reconsideration Panel, and/or PRIAD can refer issues to the Director General for consideration for future guidance development, or recommend that an existing guidance document be revised.

During the course of its review, the SAC or Reconsideration Panel, and/or PRIAD may determine that the dispute could have been prevented at an earlier stage; that is, that there were missed opportunities for dispute prevention and/or earlier resolution. The SAC or Reconsideration Panel, and/or PRIAD can make suggestions as to how a similar dispute should be prevented or resolved at an earlier stage in the future. These recommendations will be referred to the Director of SKMD and the review division Director(s) for incorporation into the process for future submissions.

5.4 Decision by the Director General

PRIAD will forward its recommendation(s) to the Director General for decision. The Director General will make a Reconsideration decision and will inform the sponsor; copies of the Reconsideration decision will be sent to PRIAD, the review division Director and the Director of SKMD for follow-up.

5.5 Follow-up action by the Director of Submission & Knowledge Management Division (SKMD)

Once the decision is issued and communicated to the Director of SKMD and the review division Director(s), it is their responsibility to ensure that appropriate follow-up actions are taken.

Specific follow-up actions related to the submission will depend on the nature of the Reconsideration decision. If VDD's position on one or more issues under dispute is amended, then an amended decision letter will be prepared for the Director General's signature.

If the Reconsideration decision was to refer the submission back to the review division(s) for re-evaluation, the Director of SKMD and review division Director(s) are responsible for ensuring that the appropriate process is followed, and/or the appropriate information is considered in the re-evaluation. In this situation, the submission will be placed in the queue based on its original target date (this will place the submission near or at the front of the queue). As the original target will likely have passed, the Director of SKMD will ensure a new target date is set and communicated to the sponsor. The new target will be set on a case-by-case basis, depending on such factors as the number of issues involved, the quantity of data to be reviewed, the complexity of the issues and the data, etc.

After each Reconsideration Decision is made, PRIAD will forward all documents generated during the Reconsideration process to SKMD. The Director of SKMD will ensure that the documents generated during the review of the Request for Reconsideration are appropriately filed and tracking is complete. The Director of SKMD and review division Director(s) should ensure that the decision is integrated into the drug submission process and decision making framework, and therefore sets a precedent for future decisions as appropriate.

The Director of SKMD and review division Director(s) are also responsible for ensuring that any recommendations made by the SAC or Reconsideration Panel, and/or PRIAD, concerning dispute prevention or early resolution are appropriately communicated within SKMD and the review divisions, and are integrated into the submission process.

5.6 Dissemination of the Reconsideration Decision: Internally

PRIAD will inform all staff of the relevant review divisions and SKMD of the Reconsideration Decision, directing them to the decision letter and accompanying IAS.

5.7 Dissemination of the Reconsideration Decision: Externally

PRIAD will prepare a summary of the IAS, which will include a description of the issue, the information considered, and the decision, for each issue under dispute. The document will not contain proprietary or identifying information about the drug or the sponsor; rather, it will be a factual document summarizing VDD's position on a particular issue. This Summary Basis of Reconsideration Decision (SBRD) will be sent to the sponsor for review prior to publication. The sponsor will be asked to identify issues that are considered to be commercially confidential and to provide supporting rationale, within 21 calendar days. The SBRD will be posted on the Health Canada web site.

A template for the SBRD is attached as Appendix 4.

6 Effective Date

This guidance document is effective as of June 18, 2009.

Appendix 1: Reconsideration Process Map

Reconsideration Process Map

Appendix 1: Reconsideration Process Map

Process Map explaining the steps through the reconsideration process

The Director General of the Veterinary Drugs Directorate issues a final decision; within the next 30 days the sponsor has the opportunity to file a Letter of Intent to the Submission and Knowledge Management Division of the Veterinary Drugs Directorate; the Submission and Knowledge Management Division has five days to determine whether or not the decision is eligible for reconsideration; if the answer is no the Submission and Knowledge Management Division contacts the sponsor to discuss dispute resolution options; the Director General then refuses the Request for Reconsideration. If the answer is yes the Submission and Knowledge Management Division acknowledges the Letter of Intent and forwards it to the Policy, Regulatory and International Affairs Division of the Veterinary Drugs Directorate; within the next 45 days, the sponsor files two copies of the Request for Reconsideration to the Submission and Knowledge Management Division; within five days the Submission and Knowledge Management Division acknowledges the request and forwards the Request for Reconsideration to the Policy, Regulatory and International Affairs Division; the Policy, Regulatory and International Affairs Division assesses the request to determine if all the information is relevant to the issue under dispute; if no; the sponsor must decide to either submit a refile submission or not; if the sponsor decides to submit a refile submission the sponsor must decide if the Request for Reconsideration should continue without the refused information; if the answer is no the sponsor withdrawals the Request for Reconsideration, and the refile submission continues; if the answer is yes, the Director General refuses the information and the Request for Reconsideration continues (this same outcome would be reached if the sponsor decides not to submit a refile submission); the Policy, Regulatory and International Affairs Division reviews the information and makes recommendation to the Director General regarding the process for disposition of Request for Reconsideration (if all the information was previously assessed by the Policy, Regulatory and International Affairs Division to be relevant to the issue under dispute, the process would move directly to this step - in any case15 days are allotted between the Submission and Knowledge Management Division acknowledging and forwarding the Request for Reconsideration to the Policy, Regulatory and International Affairs Division and this step); within 5 days, the Director General sends a letter to the sponsor; the Director General decides to either A seek external advice or B not seek external advice.

If the Director General decides option B and doesn't seek external advice, then the Policy, Regulatory and International Affairs Division holds the meeting with presentations to the Director General by the sponsor and review divisions within 30 days (or 15 days if via teleconference); the Policy, Regulatory and International Affairs Division analyses all of the information; in the next 21 days, the Policy, Regulatory and International Affairs Division prepares an Issue Analysis Summary to the Director General with recommendations; within the next 5 days the Director General issues a decision to the sponsor copying the Submission and Knowledge Management Division, Policy, Regulatory and International Affairs Division, and review division directors; the Director of the Submission and Knowledge Management Division ensures appropriate follow-up action is taken; the Policy, Regulatory and International Affairs Division disseminates the decision to the Submission and Knowledge Management Division and the review divisions; the Policy, Regulatory and International Affairs Division prepares and posts the Summary Basis of Reconsideration Decision; the Director of the Submission and Knowledge Management Division and review division directors ensure the decision is incorporated into the submission process and review decisions.

If the Director General decides option A and seeks external advice, the first step is to decide if the issues should be referred to an existing Scientific Advisory Committee; if the answer is yes the Policy, Regulatory and International Affairs Division sets the meeting date, drafts the questions and background package with the sponsor and review division input; if the Director General decides not to go with an existing Scientific Advisory Committee, the Policy, Regulatory and International Affairs Division examines nominations from sponsor and review divisions to create a Reconsideration Panel; the Policy, Regulatory and International Affairs Division sends a memo to the Director General with recommendations for the membership and chair of the Panel; the Policy, Regulatory and International Affairs Division then contacts the nominees for interest and availability; the Policy, Regulatory and International Affairs Division sends a memo to the Director General recommending the Panel membership; the Policy, Regulatory and International Affairs Division gets security clearance for the Panel members and writes the contracts; the Policy, Regulatory and International Affairs Division then sets the meeting date, drafts questions and background package with sponsor and review division input (at this point, the processes are merged whether or not the issues are referred to an existing Scientific Advisory Committee); the Policy, Regulatory and International Affairs Division holds the meeting with presentations to the Director General and the panel by the sponsor and review divisions (30 days from the date option A is chosen in the case of a Scientific Advisory Committee or teleconference or 60 days from the date option A is chosen in the case of a Reconsideration Panel); within the next 7 days the Chair submits a report; the Policy, Regulatory and International Affairs Division has 7 days to analyse all of the information; in the next 21 days, the Policy, Regulatory and International Affairs Division prepares an Issue Analysis Summary to the Director General with recommendations; within the next 5 days the Director General issues a decision to the sponsor copying the Submission and Knowledge Management Division, Policy, Regulatory and International Affairs Division, and review division directors; the Director of the Submission and Knowledge Management Division ensures appropriate follow-up action is taken; the Policy, Regulatory and International Affairs Division disseminates the decision to the Submission and Knowledge Management Division and the review divisions; the Policy, Regulatory and International Affairs Division prepares and posts the Summary Basis of Reconsideration Decision; the Director of the Submission and Knowledge Management Division and review division directors ensure the decision is incorporated into the submission process and review decisions.

Reconsideration Process Map - Part 1

Reconsideration Process Map - Part 2

Legend

Legend

Reconsideration Process Map - Legend (Process step; Decision; Document produced; Data input; Terminator)

Reconsideration Process Map - Legend

Abbreviations

DG: Director General, Veterinary Drugs Directorate
IAS: Issue Analysis Summary
MORS: Guidance for Industry: Management of Regulatory Submissions
Panel: Reconsideration Panel
PRIAD: Policy Regulatory and International Affairs Division
RR: Request for Reconsideration
SAC: Science Advisory Committee
SBRD: Summary Basis of Reconsideration Decision
SKMD: Submission & Knowledge Management Division
SRN: Screening Rejection Notice
VDD: Veterinary Drugs Directorate

Appendix 2: Performance Targets: Reconsideration Process

Section Step in Reconsideration Process Output of Step Performance Targets (calendar days) SRN and NON
5.1.1 Sponsor files Letter of Intent. Letter of Intent filed to SKMD 30
(from date of original decision)
SKMD determines eligibility of decision for reconsideration. If decision is eligible: acknowledgement letter issued. Letter of Intent forwarded to PRIAD.
If decision is not eligible: sponsor contacted, Request for Reconsideration refused.
5
(from date of receipt in SKMD)
5.1.2 Sponsor files Request for Reconsideration. Request for Reconsideration filed to SKMD. 45
(from date of acknowledgement letter)
SKMD acknowledges and processes Request for Reconsideration. Acknowledgement letter issued; Request for Reconsideration forwarded to PRIAD. 5
(from date of receipt in SKMD)
5.2.1 PRIAD, SKMD (with review division(s) as needed) assess information filed for relevance. If information is not relevant: information refused; Request for Reconsideration may continue; Refile submission may be submitted.
If information is relevant: Request for Reconsideration continues.
15
(from date of receipt in PRIAD)
5.3 PRIAD reviews information and sends memo to DG with recommendation re: appropriateness of seeking external advice. Issues clearly defined; initial analysis of positions conducted; memo written to DG with proposed process for disposition of the Request for Reconsideration.
DG makes decision re: relevance of information filed, appropriateness of seeking external advice. Letter to sponsor issued. 5
(from date of receipt in Director General's office)
5.3.1 Review by external panel:
PRIAD creates Reconsideration Panel (if applicable), holds SAC/ Reconsideration Panel meeting.

If Reconsideration Panel is formed: chair and members chosen; contracts drafted and signed; and conflict of interest & security clearance requirements met.

Questions for SAC/Reconsideration Panel drafted; meeting held; presentations made; questions answered.

If Reconsideration Panel is formed: 601
(from date of letter to sponsor (5.3))

If issues are referred to existing SAC or sponsor chooses to hold meeting by teleconference: 301
(from date of letter to sponsor (5.3))

Chair of SAC/Reconsideration Panel submits report. Report submitted to PRIAD. 7
(from date of panel meeting)
5.3.2 Review by PRIAD:
PRIAD holds meeting with DG, sponsor, review division(s).
Meeting held; presentations made.

30
(from date of letter to sponsor (5.3))

If sponsor chooses to meet by teleconference: 15
(from date of letter to sponsor (5.3))

5.3.3
5.3.4
PRIAD analyses issues, consults as necessary, drafts IAS. IAS drafted, including Recommendation(s). 21
(from the later of date of finalization of report (5.3.1) or of meeting (5.3.2))
5.4 DG makes Reconsideration decision Decision letter issued to sponsor. 5
(from date of receipt in Director General's office)

1 Every effort will be made to meet this target; however, unforseen delays can occur as a result of conflict of interest and security clearance requirements, and the need to accommodate schedules of external experts.

Appendix 3: Request for Reconsideration Template

Request for Reconsideration
(File two copies)

Section A -
Administrative Section

Brand (Proprietary) Name, or
Licence Application/Amendment Subject

Manufacturer/Sponsor Name

Contact Person for this Request for Reconsideration:

Name:
Telephone no.:
Fax no.:
E-mail address:

Proper, Common or Non-proprietary Name of Medicinal (Active) Ingredient(s)

Dosage Form(s)/Strength(s)

Route(s) of Administration

Section B -
Submission Tracking Identifiers

Submission Type
(check one)

□ NDS
□ S/NDS
□ NC
□ ANDS
□ S/ANDS
□ Admin NDS

Control No.

CR File No.

Decision for which Request for Reconsideration is filed (check one)
(attach copy of decision letter)

□ Screening Rejection Notice
□ Notice of Noncompliance

Date of issuance of decision for which Request for Reconsideration is filed

Section C -
Definition of Issue(s) and Grounds of Dispute

This section should be a brief, high-level summary of the issue(s) in dispute, and should not introduce new issues.

In this section the sponsor should include statements, in numbered paragraphs, with the definition of the issue(s) of contention, linking closely with the points of the original decision (attached). For each issue identified, the grounds of the dispute should be provided in numbered paragraphs. The grounds should be cross-referenced to the information filed in the original submission (and/or the response to a Screening Deficiency Notice or Notice of Deficiency, if applicable). The issues and grounds should not exceed a total of 20 pages (not including supporting references).

Section D -
Reconsideration Process

In this Section the sponsor should indicate its preferred mechanism for resolution of the Request for Reconsideration (i.e. referral of one or more issues to an existing SAC or to a newly created Reconsideration Panel, review of one or more issues by PRIAD, or a combination of the two). The sponsor should also indicate whether an expedited process for obtaining external advice should be followed (if possible), as outlined in Section 5.3.1(c) of the guidance document.

Section E -
Nominees for a Reconsideration Panel

In this Section the sponsor should include nomination(s) for one member of the Reconsideration Panel with expertise relevant to the resolution of the matter, as outlined in Section 5.3.1(b) of the guidance document. To ensure that nominees can comply with conflict of interest requirements the sponsor should not contact nominees and should not provide them with any material for review prior to the official appointment of the member by the Director General. The nominees should not have been involved with the sponsor for the product in question and should not have expressed their views regarding the product in question.

Appendix 4: Summary Basis of Reconsideration Decision Template

Summary Basis of Reconsideration Decision (SBRD)

<Brief description of issue under dispute, e.g. "Applicability of Health Canada Policy Bioequivalence of Proportional Formulations - Solid Oral Dosage Forms">

Date: yyyy/mm/dd

Foreword

Health Canada's Summary Basis of Reconsideration Decision (SBRD) documents outline the scientific and regulatory considerations that factored into Health Canada's decision to grant or deny a Request for Reconsideration filed as per the Health Canada Guidance Document: Reconsideration of Decisions Issued for Veterinary Drug Submissions. The SBRD has been prepared in such a way that allows stakeholders to be aware of decisions made, without disclosing potentially confidential information about a submission.

Summary Basis of Reconsideration Decision

The sponsor filed a <type of submission> for <brief description of submission, e.g. 'proposing a change in tablet formulation for the treatment of the signs of congestive heart failure in veterinary patients.'> to the <Veterinary Drugs Directorate>. <Brief explanation for the reasons for the negative decision, e.g. 'A Notice of Noncompliance was issued on the basis that there was insufficient data to support the safety and efficacy of the drug. The clinical trial had insufficient numbers of patients studied long term.'>

The sponsor filed a Request for Reconsideration of the <decision>, stating that <brief summary of the sponsor's description of the issues>.

<Brief description of the process for Reconsideration and the Reconsideration decision, e.g. 'The VDD upheld the original decision on the grounds that the above-referenced HC policy clearly applies to this submission, and therefore ....' or 'The issue was referred to the Reconsideration Panel, who agreed with the sponsor's position and recommended that the submission be referred back to the review division(s) for re-evaluation. The Policy Regulatory and International Affairs Division concurred with the Reconsideration Panel's recommendation. The Director General of VDD referred the submission back to the review division(s); all issues were subsequently resolved and a Notice of Compliance was issued.'>

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