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Veterinary Biologics Guideline 3.1E

Summary of Requirements and Guidelines for Veterinary Biologics in Canada

TABLE OF CONTENTS

I. INTRODUCTION

This summary of requirements has been prepared to provide manufacturers of veterinary biologics, Canadian or foreign, with a frame-work for preparing their submissions. Included is a check-list entitled New Product Submission Check-List that outlines the information and material required by the Veterinary Biologics Section for a new product submission.

All information provided by the company is for the use of the Veterinary Biologics Section staff only, and is held in strict confidence.

Legislation

The authority for the regulation of veterinary biologics is the Health of Animals Act and Regulations, the Financial Administration Act and the Canadian Food Inspection Agency Fees Notice - Part 11, Services Related To Veterinary Biologics (Items 40 - 50).

Definition

Veterinary biologic means (a) any helminth, protozoa or micro-organism, (b) any substance or mixture of substances derived from animals, helminths, protozoa or micro-organisms, or (c) any substance of synthetic origin that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in animals. These veterinary biological products include vaccines, bacterins, bacterin-toxoids and diagnostics kits.

General Criteria for Product Acceptability

1. The product must be pure, safe, potent and efficacious.

2. The product must be licensed by, or have the approval of, the regulatory authorities in the country of origin.

3. Each biologically active component must be relevant to Canadian disease conditions.

4. The product must be produced and tested in accordance with generally accepted "good manufacturing practices" and "current state of the art".

A Product May Be Found Unacceptable for Importation Into Canada for One Or More of the Following Reasons

1. Products containing components originating from countries where foot and mouth disease, rinderpest, African swine fever, African horse sickness, and other diseases exotic to Canada are endemic.
2. Products for use against diseases absent in Canada, such as hog cholera, bluetongue, vesicular stomatitis, anaplasmosis and pseudorabies.
3. Products for the prevention or diagnosis of diseases which are under an Canadian Food Inspection Agency control or eradication program.
4. Products which are improperly labelled.
5. Products which may not be in the best interest of or may be contrary to public health control or survey programs. An example would be the use of live Salmonella spp. vaccine in calves.
6. Products containing certain virulent strains of viruses, as for example, virulent strains of infectious laryngotracheitis virus or virulent Newcastle Disease viruses (mesogenic and lentogenic strains).
7. Products derived from the infected tissues of animals in which there would be a significant risk of extraneous virus contamination.
8. Products for which the safety and/or efficacy have, in the opinion of the Canadian Food Inspection Agency, not been satisfactorily established.
9. Products which may have previously been imported into Canada but, for a variety of reasons, are no longer considered suitable or desirable.

II. FORMS, PERMITS & LICENCES

1. Application for Permit to Import Veterinary Biologics into Canada (CFIA 1493)

This form is required of all Canadian importers. A separate form is required for each product. This form must be signed by the Canadian importer.

2. Veterinary Biologics Information Form (CFIA 1503)

This form is required of all manufacturers - Canadian and foreign. A separate form is required for each product. The form must be signed by an official of the company.

3. Permit to Import Veterinary Biologics (CFIA 1588)

This permit is issued by the Veterinary Biologics Section to the Canadian importer. It is used for importation of finished products and bulk antigens. A copy of this form should be forwarded to the manufacturer. A copy of this permit must accompany the shipment of product to Canada. Various restrictions and conditions may apply, depending on the product, country of origin, and the intended use. These restrictions and conditions will be listed on the permit, and explained in supplemental correspondence as required.

4. Veterinary Biologics Establishment Licence (CFIA 1589)

For Canadian manufacturers, this licence is issued by the Veterinary Biologics Section. American manufacturers must submit a photocopy of their USDA-APHIS Veterinary Biologics Establishment License. Manufacturers in other countries must submit a photocopy of the documentation appropriate in their country. Various restrictions and conditions may apply. These restrictions and conditions will be listed on the establishment licence, and explained in supplemental correspondence as required.

5. Veterinary Biologics Product Licence (CFIA 4602)

For Canadian manufacturers, licensed products are listed on the Veterinary Biologics Establishment Licence, which is issued by the Veterinary Biologics Section. American manufacturers must submit a photocopy of their USDA-APHIS Veterinary Biologicals Product License. Manufacturers in other countries must submit appropriate documentation. Various restrictions and conditions may be applied. These restrictions and conditions will be listed on the product licence, and explained in supplemental correspondence as required.

6. Notification of Suspected Adverse Reactions to Veterinary Biologics (CFIA 2205)

7. Application for Services (CFIA 4720)

III. FACILITIES

Plot Plans, Blueprints & Legends

These are required of all manufacturers. American manufacturers may submit copies of those submitted to the USDA-APHIS Veterinary Biologics licensing authorities.

Inspection

Inspections are conducted by Veterinary Biologics Section staff.

IV. PERSONNEL

Organizational Chart

Qualifications of Key Personnel

A résumé/curriculum vitae should be provided for managerial and supervisory personnel involved in production and quality control. Similar documents may also be submitted for key research and development staff, but it is not essential. For American manufacturers, copies of USDA-APHIS Center for Veterinary Biologics (CVB) forms are acceptable.

V. MANUFACTURING & TESTING PROTOCOLS

Canadian manufacturers should prepare production outlines and special outlines in the format described in the Guidelines for Preparation of Production Outlines, Special Outlines and Summary of Changes for Veterinary Biologics. American manufacturers may provide copies of production outlines and special outlines as submitted and approved by the USDA-APHIS Center for Veterinary Biologics (CVB). We recommend that other manufacturers submit production outlines and special outlines in the format described in the Guidelines for Preparation of Production Outlines, Special Outlines and Summary of Changes for Veterinary Biologics

For products formulated from multiple components or bulk vaccine manufactured at another manufacturing facility, the manufacturer should also provide a flow chart indicating the source(s) of all antigens.

The following information is also required:

VI. SUMMARY TEST RESULTS

Manufacturers must submit summary test results to verify uniformity, and serial-to-serial consistency of production serials. These data demonstrate the manufacturer's capability of consistently producing serials to meet production outline specifications. For new products, manufacturers should provide summary test results from 3 pre-licensing serials. For new combinations of previously licensed products, manufacturers should submit data from 2 serials, as well as non-interference data.

The test results should be submitted in an appropriate format (i.e. Manufacturer's Serial Release Test Report to VBS or USDA APHIS Veterinary Biologics Production and Test Report (Form 2008)). Test references on serial release test result forms should cite the current production outline and special outlines.

VII. SUPPORTING DATA

Data must be provided to demonstrate and support the safety, purity, potency and efficacy of the product and support label claims. This is usually provided as research & development data (including laboratory and animal studies) and field trial data. On occasion, field trial data must be generated in Canada.

The format in which this information is presented is at the discretion of the manufacturer. Copies of pertinent reprints are welcome.

Manufacturers may be required to submit samples for confirmatory testing.

VIII. LABELLING

It is recommended that draft labelling be submitted for initial approval. Final labelling must be found acceptable prior to issuance of a licence or import permit.

Labelling may be in English only or French only but, if both languages are used, then all information provided in one language must be provided in the other language. Provincial legislation in Quebec requires that labelling be in French or bilingual French-English.

Labelling originating in Canada or the U.S. generally poses no problems regarding generally accepted and understood terminology. However, the terminology used in labelling from other countries often requires modification to be readily understood by Canadian consumers.

IX. IMPORTATION

Importer

A Canadian importer must be designated by the foreign manufacturer and inspected and approved by the Veterinary Biologics Section.

Import Permits

An 'annual' Permit To Import Veterinary Biologics (CFIA 1588) is issued for the majority of products which have been found acceptable for importation, and which do not require special tests or pre-clearance. The permit is valid for one year, ending April 30 of each year.

Canada Border Services Agency Invoice

A copy of this invoice for all products imported into Canada (on single entry, temporary or annual permit) must be kept on record by the importer. This information may be requested on occasion. It is used for summary statistics only, and is kept strictly confidential.

Canadian manufacturers must maintain records on the amount of product produced, for the same reason as above.

Note: In general, the Veterinary Biologics Section requires only one copy of the required forms, protocols, draft labelling, advertising and other information provided in a product submission. Production outlines and final labelling should be submitted in duplicate (or triplicate) so that stamped copies of the approved documents can be returned to the manufacturer. Manufacturer's serial release test result forms should also be submitted in duplicate.

X. VETERINARY BIOLOGICS SECTION

XI. SUPPLEMENTAL INFORMATION, FORMS, & GUIDELINES

The following supplemental information, forms and guidelines are available from the Veterinary Biologics Section.

XII

The following form constitutes part of this guideline and is appended.

New Product Submission Check-list
(Form VBFM05.03E)

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.

Additional information about the requirements for licensing veterinary biologics in Canada is available by contacting VBS , or visiting the Internet website: http://www.inspection.gc.ca/english/animal/vetbio/vbpbve.shtml

Version:  VBGL 03.01E.01