Appendix C "Request for Human Drugs Reconsideration Template" - Canada

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Appendix C: Request for Human Drugs Reconsideration
Template
Section A – Administrative Section
Name:
Telephone:
Contact Person for this Request for Reconsideration
Facsimile:
E-mail:
Date this form is completed
Brand (Proprietary) Name, or Licence
Application/Amendment Subject
Manufacturer/Sponsor Name
Proper, Comment or Non-proprietary Name of Medicinal
(Active) Ingredient(s)
Dosage Form(s)/Strength(s)
Route(s) of Administration
Section B – Submission Tracking Identifiers
NDS
S/NDS
NC
ANDS
S/ANDS
DINA
Submission Type
CTA
CTA-A
(check one)
Application for Authorization
Application for Authorization - Amendment
Control Number
CR File Number
Screening Rejection Letter (including New Drug Letter)
Notice of Deficiency – Withdrawal Letter
Notice of Non-compliance – Withdrawal Letter
Decision for which Request for
Reconsideration is filed (check one)
Not Satisfactory Notice
(attach copy of decision letter)
Notice of Insufficient Information –Withdrawal Letter
Notice of Refusal
Rejection of Accelerated Licence Amendment Submission
Date of issuance of decision for which
Request for Reconsideration is filed
Appendix C: Request for Human Drugs Reconsideration
Template
Section A – Administrative Section
Name:
Telephone:
Contact Person for this Request for Reconsideration
Facsimile:
E-mail:
Date this form is completed
Brand (Proprietary) Name, or Licence
Application/Amendment Subject
Manufacturer/Sponsor Name
Proper, Comment or Non-proprietary Name of Medicinal
(Active) Ingredient(s)
Dosage Form(s)/Strength(s)
Route(s) of Administration
Section B – Submission Tracking Identifiers
NDS
S/NDS
NC
ANDS
S/ANDS
DINA
Submission Type
CTA
CTA-A
(check one)
Application for Authorization
Application for Authorization - Amendment
Control Number
CR File Number
Screening Rejection Letter (including New Drug Letter)
Notice of Deficiency – Withdrawal Letter
Notice of Non-compliance – Withdrawal Letter
Decision for which Request for
Reconsideration is filed (check one)
Not Satisfactory Notice
(attach copy of decision letter)
Notice of Insufficient Information –Withdrawal Letter
Notice of Refusal
Rejection of Accelerated Licence Amendment Submission
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, Notice of Deficiency, or Notice of Non-compliance). Issues not contested will remain
outstanding at the end of the Reconsideration process and will have to be addressed in a refile.
If you need additional space, list all information requested on a separate sheet of paper, add your Control Number
and CR File Number to the bottom of each sheet and attach the sheet to your application.
Appendix C: Request for Reconsideration Template - Effective Date: 2015/01/01; Administrative Changes Date: 2019/07/26
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