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VB-GL-3.4: Pre-submission consultation meetings and advance notification of new product licensing submissions

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1. Introduction

This guideline provides guidance for veterinary biologics (VB) manufacturers on the procedure for requesting a pre-submission consultation meeting with the Canadian Centre for Veterinary Biologics (CCVB) for a new product licensing submission.

2. Pre-submission consultation meetings

While general questions regarding new VB in development or VB licensing requirements can often be addressed by telephone or in writing, it is often beneficial to meet in person or in a virtual meeting to discuss more complex questions regarding the regulatory approval process and documentation requirements for specific VB products. A pre-submission consultation meeting with a CCVB reviewer can be arranged for this purpose.

Manufacturers that are currently licensed to produce veterinary biologics for Canada, as well as prospective manufacturers from Canada or other countries, may arrange a pre-submission consultation meeting with CCVB to discuss upcoming new product licensing submissions.

Foreign manufacturers should be aware that one of the prerequisites for licensing imported products is that the products must be produced in manufacturing facilities subject to government regulatory oversight in the country where they are manufactured and tested. For veterinary biologics manufactured in the United States, this authorization is granted by issuance of a United States Veterinary Biologics Establishment License.

2.1 Prerequisite

A pre-submission consultation meeting may be requested by CCVB, the manufacturer, or the designated Canadian importer. A meeting may be warranted under the following circumstances:

Pre-submission consultation meetings are not usually necessary for routine new product submissions for veterinary biologics that have completed, or are completing, the process for full licensure in the U.S., and when the product is similar to other licensed products.

2.2 Scheduling

A pre-submission consultation meeting should be scheduled after a product has completed the research and development phase, and proof of concept data have been generated by the manufacturer. A manufacturer, or its designated authorized Canadian importer, should contact the CCVB National Manager at least 1 month in advance of the meeting with the following information:

The National Manager will assess the request and assign a CCVB reviewer to coordinate the meeting.

2.3 Meeting format

A pre-submission consultation meeting is typically about 1.5 hours in duration. More time could be allocated if necessary, depending on the agenda. To begin the meeting, the industry representative usually provides a brief (20 minutes) introductory presentation. The meeting then proceeds with a discussion of background information and specific agenda items. The allotted time should be sufficient to address the majority of the questions regarding the submission. However, since some specific concerns require additional internal discussions within CCVB, a final answer on certain questions or issues might not be provided to the manufacturer or its representatives until sometime after the meeting. Industry representatives frequently find it helpful to record summary notes and confirm key items by writing a brief follow-up letter to CCVB.

3. Advance notification of new product licensing submissions

In certain instances, manufacturers may find it useful to notify CCVB in writing of upcoming new VB submissions. This advance notice will help facilitate work planning, scheduling, and the efficient use of CCVB resources during the submission screening, review, and licensing process.

3.1 Prerequisite

Written notification of upcoming submissions should be submitted to CCVB under the following circumstances:

3.2 Notification information

For advance notification, the manufacturer is requested to provide CCVB with the following information about its upcoming new product submissions:

4. Contact information

Inquiries and correspondence regarding pre-submission consultation meetings or advance notification of new product licensing submissions should be directed to the National Manager, Canadian Centre for Veterinary Biologics.

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