Please note that the timeframes shown below are targets for processing
submissions within VBS,
starting on the day applications are received in the VBS office, (assuming all relevant
documentation or samples are included).
| Veterinary Biologics Program
Service Standards (Response Times - Guidelines l105e.01) |
| Function |
Timeframe |
VBS |
BEL |
| 1. |
Dossier Review (new submission, change in
product formulation or change in label claim) |
. |
Yes |
Yes |
| 1.a) |
Canadian Manufacturers
Review initial submission and prepare response *
Average response time
Maximum response time
Review supplemental data and prepare response *
Average response time
Maximum response time |
.
.
3 months
4 months
4 weeks
6 weeks
|
. |
(Review test methods) |
| 1.b) |
American Manufacturers (review emphasis on
Canadian requirements)
Review initial submission and prepare response *
Average response time
Maximum response time
Review supplemental data and prepare response *
Average response time
Maximum response time |
.
.
.
3 months
4 months
4 weeks
6 weeks
|
Yes |
No |
| 1.c) |
Manufacturers from other countries
Review initial submission and prepare response *
Average response time
Maximum response time
Review supplemental data and prepare response *
Average response time
Maximum response time |
.
.
4 months
6 months
4 weeks
6 weeks
|
Yes |
Yes
(Review test methods)
|
| * Licensing submissions must conform with VBS documentation requirements,
as specified in Summary of Requirements and Guidelines for Veterinary
Biologics in Canada and supplemental guidelines. Submissions with major
omissions would not be reviewed. |
| 1.d) |
Laboratory testing as referred to in Item 1 or Item
7
(i) each master cell line *
Average response time
Maximum response time
(ii) each master seed culture *
Average response time
Maximum response time
(iii) each pre-licensing serial tested, to a
maximum of three *
Average response time
Maximum response time
* Response times are subject to factors such as reagent availability.
|
.
.
3 months
4 months
.
3 months
4 months
.
.
3 months
4 months
|
.
.
No
.
.
No
.
.
.
No
|
.
.
Yes
.
.
Yes
.
.
.
Yes
|
| 2. |
Facility Inspections/Audits
a) Canadian manufacturers
b) Canadian importers
c) American manufacturers
d) Other non-Canadian manufacturers
* For facilities which are inspected annually and licensed by a recognized
equivalent federal agency such as USDA-APHIS, VBS would inspect new manufacturers.
Others would be inspected annually by USDA-APHIS or equivalent, and
manufacturers would submit copies of inspection reports. VBS would reserve the right to inspect
manufacturers more frequently, if necessary.
|
.
Annual
3 years
USDA*
4 years |
Yes
.
.
.
Yes |
Yes
.
.
.
Yes |
| 3. |
Issuance of Permits, Licenses and Export
Certificates
Annual import permits, Product licences, Establishment licences, ad hoc
revisions (minor), Permits to import veterinary biologics for investigational
or emergency use.
(Under the current Health of Animals Regulations, permits and
licences expire at the end of each fiscal year. If appropriate, these should be
renewed before the expiry date, April 30th of each year.)
|
.
2 weeks |
Yes |
No |
| 4. |
Serial Release
If not tested
BEL average
response time
BEL maximum
response time
VBS average response
time
VBS maximum response
time
If tested
VBS and BEL average response time
VBS and BEL maximum response time
* Working days
|
.
.
2-3 days *
5 days *
2 days *
5 days *
.
35 days *
45 days *
|
Yes |
Yes/No |
| 5. |
Label Review (and approval)
Average response time
Maximum response time
(Minor changes only, for substantial changes, see #1 above.)
|
.
2 weeks
4 weeks |
Yes |
No |
| 6. |
Advertising Review (and approval) *
Average response time
Maximum response time
* Changed regulations. Advertising reviews are voluntary.
|
.
2 weeks
4 weeks |
Yes |
No |
| 7. |
Protocol Review for Efficacy/Safety Studies
(On request, allows 45 days at BEL.) |
2 months |
Yes |
Yes/No |
| 8. |
Production Outline Revisions
Average response time
Maximum response time
(Minor changes only, for substantial changes, see #1 above.)
|
.
2 weeks
4 weeks |
Yes |
Yes/No
(Review test methods)
|
| 9. |
Suspected Adverse Reactions
Average response time
Maximum response time
(Report all cases involving veterinary intervention, mortality, or
significant illness or production loss, as required by the Health of Animals
Act, 135.1).
|
.
2 weeks
4 weeks |
Yes |
Yes/No |
