Language selection


VB-GL-3.6: Bluetongue virus exclusion testing of veterinary biologics

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

On this page

1. Introduction

To prevent the transmission of bluetongue virus (BTV) through veterinary biologics (VB), the Canadian Centre for Veterinary Biologics (CCVB) requires manufacturers to conduct BTV exclusion tests on live virus vaccines which are intended for use in ruminants. Other products such as live bacterial vaccines intended for use in ruminants will require BTV exclusion tests, if significant quantities of ruminant serum are used in the manufacturing process.

1.1 Legal Authority

2. Guidance

2.1 Testing requirements

For live vaccines, which are intended for use in ruminants and are produced using either non-irradiated ruminant serum or primary ruminant cells, manufacturers are required to conduct BTV exclusion testing. Tests may be carried out on raw materials or on finished serials as described below. The test option and test method must be pre-approved by CCVB.

Option 1 - Testing of raw material of ruminant origin which is not subjected to a sterilization process

Option 2 - Testing of each serial of the final product

2.2 Conditions for a waiver of testing requirements

The BTV exclusion testing may be waived if all of the following conditions are met and are documented in the Outline of Production:

3. Related guidelines

4. Contact information

Any further questions or clarification regarding the regulations and requirements pertaining to BTV exclusion testing of VB may be directed to the CCVB.

5. Memorandum template


To: [Manufacturer name and address]
From: [Importer name and address]
Subject: List of serials eligible for importation under the [importer-manufacturer company names] permit to import veterinary biologics

This will confirm that I have reviewed the test results for the product serial(s) listed below, and verified that they conform with the testing requirements and permit conditions as described on the current permit to import veterinary biologics.

A copy of this memorandum must accompany the shipment. It will be retained on file at [Importer name].

  1. [CCVB file number] [USDA product code (PCN)]
    [Assigned name] [trade name];
    [Serial Number]; [Expiration date - yyyy-mm-dd]
    [Serial Number]; [Expiration date -yyyy-mm-dd]

  2. [CCVB file number] [USDA product code (PCN)]
    [Assigned name] [trade name];
    [Serial Number]; [Expiration date -yyyy-mm-dd]
    [Serial Number]; [Expiration date -yyyy-mm-dd]

[Signature, importer's authorized representative] [Date]
[Name, importer's authorized representative]
[Importer company name]

Date modified: