The following is a list of key documents required to support an
application for licensing a new veterinary biologic 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.
| |
1 |
Covering letter introducing the submission and
identifying the regulatory liaison. |
| |
2 |
Application For Services (Form CFIA-4720) and applicable
fees. |
| |
3 |
Veterinary Biologic Information (Form CFIA-1503) signed by the Canadian
or foreign manufacturer. |
| |
4 |
Application For Permit To Import Veterinary Biologics
(Form CFIA-1493) -
(for imported products only). |
| |
5 |
References supporting rationale for use of veterinary biologic
in Canada. |
| |
6 |
Outline of Production (with corresponding APHIS 2015 and Summary of
Changes for US products). |
| |
7 |
Referenced Outlines of Production, Special Outlines and
scientific literature. |
| |
8 |
Draft labels. |
| |
9 |
Copy of USDA Veterinary
Biological Establishment License, or equivalent (for non Canadian
product). |
| |
10 |
Copy of USDA Veterinary
Biological Product License, or equivalent (for imported products). A new
product must be licensed in the country of origin. |
| |
11 |
Data to support purity, safety and identity of master
seeds. |
| |
12 |
Data to support purity and identity of master cell stocks. |
| |
13 |
Master seed genetic characterization data, if biotechnology
derived product. |
| |
14 |
Copy of report(s) on host animal immunogenicity/efficacy, as
well as study protocols if methods are not fully described in the final
report(s). |
| |
15 |
Non interference data (for multi-component product). |
| |
16 |
Data to support genetic stability of the micro-organisms, back
passage study (for live vaccine). |
| |
17 |
Copy of report(s) on product safety (laboratory and field data),
as well as safety study protocols if methods are not fully described in the
final report(s). |
| |
18 |
Data to support correlation between potency test and host animal
efficacy (in vitro or in vivo procedures). |
| |
19 |
Data to support non viricidal activity of inactivated liquid
biologics used as a diluent for a desiccated live virus vaccine in a
combination package. |
| |
20 |
Copy of blank form Manufacturer's Serial Release Test
Report to VBS
(VBFM05.02) for products requiring serial release by VBS. |
| |
21 |
Summary of test results from three (3) consecutive prelicensing
serials. |
| |
22 |
Stability data to support the proposed expiration dating
(Accelerated or real time). |
| |
23 |
Bluetongue virus exclusion test results (for modified live virus
vaccine for ruminants). |
| |
24 |
Pseudorabies virus exclusion test results (for modified live
virus vaccine for pigs). |
| |
25 |
Risk analysis for environmental assessment (required for
products containing micro-organisms or isolates not present in Canada, and for
novel or biotechnology-derived products). |
| |
26 |
Other documents if required (please list)
__________________________________
__________________________________ |
