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Veterinary Biologics Guideline 3.8E

Guidelines for Autogenous Veterinary Biologics for Use in Fish

A. INTRODUCTION

The purpose of this guideline is to provide information on requirements for manufacture and importation of autogenous fish biologics in Canada.

The authority for regulating veterinary biologics, including autogenous biologics, is provided in the Health of Animals Act¹ and Regulations². The Veterinary Biologics Section (VBS) of the Canadian Food Inspection Agency (CFIA) is responsible for licensing and regulating veterinary biologics in Canada.

The cost recovery fee schedule for veterinary biologics is specified in the Canadian Food Inspection Agency Fees Notice - Part 11, Services Related To Veterinary Biologics (Items 40-50), ³. The services and fees are listed in the 'Summary of Fees and Services Related to Veterinary Biologics' on the reverse side of the Application For Services (Form CFIA 4720).

B. DEFINITION AND DESCRIPTION

Autogenous biologics are recommended for emergency use only. They are prepared in response to a specific and immediate need, usually when a disease problem arises which is not amenable or responsive to the usual therapeutic measures or when licensed products are not available.

Autogenous biologics are prepared from cultures of microorganisms isolated from infected fish and are further described and characterized for the purpose of these guidelines as follows:

1. Autogenous biologic shall consist only of inactivated cultures or cell-free extract of microorganisms.

2. Each isolate from a diagnostic specimen shall be identified, at least to genus level.

3. Ordinarily, autogenous biologics shall be monovalent. However, an autogenous biologic containing multiple organisms may be prepared and used at the discretion of the attending licensed veterinarian. Autogenous biologics should not be mixed with licensed products because there are no supporting data to evaluate the impact of the autogenous product on the safety and efficacy of the licensed product.

4. These microorganisms are judged by the attending licensed veterinarian or diagnostic laboratory to be the cause of the current infectious disease. A proper veterinarian/client/patient relationship is a prerequisite to autogenous biologics use. The veterinarian will coordinate disease diagnosis, organism isolation and identification, and location for vaccine use. Associated diagnostic work may be undertaken at any laboratory with appropriate capabilities.

5. Information About the Disease Problem: Each application for the autogenous biologic should be accompanied with information about the specific disease problem. Information such as, names, addresses and phone numbers of the owner and attending veterinarian, date of the incidence, tentative diagnosis, dates of specimen collection and/or isolation of the causative agent should accompany the application. This information may be provided by the attending licensed veterinarian.

6. Autogenous biologics are to be used only at facilities from which the microorganism was isolated, or other adjacent or related facilities judged by a licensed veterinarian to be at risk.

7. Only the amount of autogenous biologic needed for the facilities at risk, not to exceed three inoculations, should be produced. Any autogenous biologic left over after final vaccination should be destroyed.

8. Strains of microorganisms used for the production of autogenous veterinary biologics may not be introduced into commercial vaccine manufacturing facilities.

9. Each serial must be tested to verify safety, inactivation and freedom from contaminants as described in the approved production outline. It is the responsibility of the manufacturer to maintain appropriate quality assurance procedures.

10. The expiration date for the autogenous biologic should not exceed twelve months from the date of harvest.

11. A permanent record and a copy of the label used for each autogenous biologic should be maintained and made available to VBS staff when requested during an inspection.

12. In those circumstances which are not addressed by the guidelines, the manufacturer may apply to the VBS for special permission to make the autogenous biologic to meet these needs. The special request will be evaluated on a case-by-case basis.

The application for autogenous biologics should be submitted to:

Veterinary Biologics Section, Canadian Food Inspection Agency,
2 Constellation Crescent
Ottawa, Ontario K1A 0Y9
Canada

C. MANUFACTURERS ARE REQUIRED TO SUBMIT THE FOLLOWING MATERIALS TO LICENSE AN AUTOGENOUS BIOLOGIC IN CANADA

1. An Application for Services (Form CFIA 4720) with appropriate fees (for applicable fees, please see the fee schedules for Canadian and United States manufacturers of autogenous biologics in the respective sections of the guidelines).
2. A Veterinary Biologic Information Form (Form CFIA 1503)
3. A production outline describing production and testing methods for the autogenous biologics as follows:

a.	Autogenous Bacterins
A generic production outline for the autogenous bacterin. A separate production outline will be required for each autogenous biologic if the production and testing methods differ significantly from the generic production outline.
b.	Autogenous Viral Vaccines
A separate production outline for each autogenous viral biologic.

4. The labelling for the autogenous biologics should contain the following information. A generic label containing the information listed under items 'a', 'd', 'h' and 'i' should be submitted with the initial application.

a.	Autogenous Biologic (bacterin, vaccine, toxoid), followed by the name of the microorganism used in the preparation of the product.
b.	Name and address of the attending licensed veterinarian.
c.	Name, address and establishment licence number of the manufacturer.
d.	Preservatives and inactivating agents used in the autogenous biologic.
e.	Expiration date and serial number of the product (The expiration date for the autogenous biologic should not exceed twelve months from the date of harvest).
f.	Dosage, recommended route of administration, frequency of vaccination and withdrawal period.
g.	Storage conditions.
h.	The label should include the following cautionary statements: "For veterinary use only. Do not vaccinate within 21 days (or more depending on the type of the adjuvant used) before slaughter. Autogenous biologic is used in an emergency situation when a licensed product is not available to prevent the spread of a disease to healthy fish. Potency and efficacy of this biologic have not been established. This product has been prepared for use only by or under the direct supervision of a licensed veterinarian."
i.	Additional cautionary statements or warnings as required.

Upon review and approval of the above materials, a generic Veterinary Biologics Product Licence for autogenous biologic will be issued to Canadian manufacturer.

The fee schedule for autogenous biologics for Canadian manufacturers as listed under 'Summary of Fees and Services Related to Veterinary Biologics' of the Application for Services (Form CFIA 4720) is as follows:

D. ADDITIONAL REQUIREMENTS FOR THE IMPORTATION OF AUTOGENOUS BIOLOGICS FROM UNITED STATES

The United States manufacturers may also prepare autogenous biologics for use in Canada. The United States manufacturers are also advised to consult the Code of Federal Regulations and associated guidelines. In addition to the requirements listed in the sections B and C above, the United States manufacturers are required to submit the following materials:

1. A copy of the USDA Veterinary Biologics Establishment Licence

2. A copy of the USDA Veterinary Biological Product Licence

Upon review and approval of the above materials, the product will be registered for importation into Canada. The Canadian importers are required to submit the following materials to VBS before importing a registered autogenous biologic from the United States:

1. A completed Application for Services (Form CFIA 4720) with the appropriate fee (for applicable fees, please see the fee schedule for the United States manufacturers).

2. An Application for Permit to Import Veterinary Biologics (Form CFIA 1493).

3. Information about the disease problem as indicated in Section B(5.).

4. Summaries of test results by manufacturer on APHIS 2008 for the specific serial of autogenous biologic to be imported.

5. Data to support the inactivation of the virus must be submitted and approved before the permit for the autogenous viral product is issued.

Upon approval of the application, a single entry Permit to Import Veterinary Biologics will be issued for a specific serial of the autogenous biologic.

The fee schedule for autogenous biologics manufactured in the United States as listed under 'Summary of Fees and Services Related to Veterinary Biologics' of the Application For Services (Form CFIA 4720) is as follows (the fees are shown in Canadian funds):

E. REFERENCES

1. Health of Animals Act, Section 64 (1) (s)
2. Health of Animals Regulations, Part XI, Sections 120 - 135
3. Canadian Food Inspection Agency Fees Notice - Part 11, Services Related To Veterinary Biologics (Items 40-50)