The following is a list of key documents required to support an application
for licensing a diagnostic kit in Canada. In special circumstances, additional
documents may be required. To ensure completeness of submissions, this
check-list must accompany all applications. The titles may be used to generate
a table of contents and section headings for submissions.
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1 |
Covering letter introducing the submission and
identifying the regulatory liaison. |
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2 |
Application For Services (Form CFIA-4720) and applicable
fees. |
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3 |
Veterinary Biologic Information (Form CFIA-1503) signed by the Canadian
or foreign manufacturer. |
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4 |
Application For Permit To Import Veterinary Biologics
(Form CFIA-1493) -
(for imported products only). |
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5 |
References supporting rationale for use of diagnostic kit in
Canada. |
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6 |
Outline of Production (with corresponding APHIS 2015 and Summary of
Changes for US products). |
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7 |
Referenced Outlines of Production, Special Outlines and
scientific literature. |
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8 |
Serial Release Specifications. |
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9 |
Draft labels. |
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10 |
Copy of USDA
Veterinary Biological Establishment License, or equivalent (for non
Canadian product). |
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11 |
Copy of USDA Veterinary
Biological Product License, or equivalent (for imported products). A new
product must be licensed in the country of origin. |
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12 |
Data to support purity and identity of master seeds if microbial
antigen is used in the kit. |
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13 |
Data to support purity and identity of master cell (hybridomas)
stocks if monoclonal antibody is used in the kit. |
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14 |
Copy of report(s) on the kit's performance evaluation
studies, as well as study protocols if methods are not fully described in the
final report(s). |
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15 |
Data on absence of cross-reactivity. |
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16 |
Data to support the reproducibility of the kit performance
(equivalent to in vitro potency). |
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17 |
Copy of blank form Manufacturer's Serial Release Test
Report to VBS
(VBFM05.02) for products requiring serial release by VBS. |
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18 |
Summary of test results from three (3) consecutive prelicensing
serials. |
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19 |
Stability data to support the proposed expiration dating
(Accelerated or real time). |
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20 |
Other documents if required (please list)
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