Veterinary Biologics Guideline 3.4E
Guideline for Pre-Submission Consultation Meetings and Advance Notification of New Product Licensing Submissions

Table of Contents

I. Introduction

This guideline is intended to provide guidance for veterinary biologics manufacturers on the procedure for requesting a pre-submission consultation meeting with the Canadian Centre for Veterinary Biologics (CCVB) of the Canadian Food Inspection Agency and to outline the conditions under which a manufacturer should provide CCVB with advance notice of new product licensing submissions.

II. Pre-Submission Consultation Meetings

While general questions regarding new veterinary biologics in development or veterinary biologic licensing requirements and procedures can often be addressed by telephone or in writing, it is often beneficial to meet in person to discuss more complex questions regarding the regulatory approval process and documentation requirements for specific veterinary biologic 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.

A. Prerequisite

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

  • For a new veterinary product for which the regulatory jurisdiction is not clear (e.g. veterinary biologic regulated under Health of Animals Act and Regulations versus veterinary drug regulated under Food and Drugs Act and Regulations);
  • For new classes of veterinary biologics, or novel uses of existing products, where the technical licensing requirements are not yet clearly established;
  • For veterinary biologics that are conditionally licensed in the US and are urgently required in Canada, to address a significant animal health, public health, or food safety concern; or
  • For other special circumstances, on a case-by-case basis.

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 US, and when the product is similar to other licensed products.

B. 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 National Manager at least one month in advance of the meeting with the following information:

  1. Assigned name of the veterinary biologic product;
  2. Brief description of product and proposed label claim;
  3. Draft agenda for the meeting;
  4. List of specific questions and issues to be discussed;
  5. Tentative list of participants representing the manufacturer;
  6. Background information including a summary of proof of concept data, whether the product is derived from biotechnology, and a list of materials of animal origin used in the development and manufacture of the product; and
  7. Proposed date(s) for the meeting, including preference for time of day (am/pm), and one or more alternative dates, to facilitate scheduling.

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

C. Meeting Format

A pre-submission consultation meeting is typically about 1.5 hours in duration; however, 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.

III. Advance Notification of New Product Licensing Submissions

In certain instances (see III.A below), manufacturers may find it useful to notify CCVB in writing of upcoming new veterinary biologic 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.

A. Prerequisite

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

  • For the licensing of a group of related products with clustered or sequential submission dates;
  • For the introduction of a ‘next generation' product line to update and replace an existing licensed product line;
  • Where the production of an existing licensed product line will cease or has ceased; or
  • For acquisitions and mergers where a group of new product licensing submissions will be submitted.

B. Notification Information

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

  1. Detailed background information about existing and updated veterinary biologics including the rationale for the product line change.
  2. A list outlining the next generation veterinary biologic product line to be considered for Canadian licensure including:
    1. USDA APHIS Veterinary Biological Product Code (for US products)
    2. Assigned name
    3. Status of licensure in the country of origin
    4. The anticipated submission date
    5. Name and address of the licence holder
  3. A list of existing veterinary biologic products to be replaced including:
    1. CCVB file number
    2. USDA APHIS Veterinary Biological Product Code (for US products)
    3. Assigned name
    4. Current manufacturing or inventory status
    5. Name and address of the licence holder

IV. 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.