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Licensing a Biologic: Suggestions for

New Applicants

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New applicants are encouraged to contact the Center for Veterinary Biologics (CVB)

early in the product development process. A licensing reviewer will be assigned to

help you through the regulatory process. Initially, the CVB will confirm that the

proposed product meets the definition of a veterinary biologic and is subject to

regulation by the CVB. 

The proposed manufacturing and testing facilities must also meet the standard

requirements as outlined in the 9 CFR, Part 108. Manufacturing facilities located in

communal buildings, such as University Research Parks or New Business Incubator

buildings may not meet the control and quality standards required for the

manufacturing of a veterinary biological product. These shared spaces bring with
them a host of issues not seen with a traditional manufacturing setting. A reminder

to new applicants considering a communal manufacturing site; the entire building

would be considered licensed premises and as such the entire building would be

subject to inspection by the Center for Veterinary Biologics. 

We then recommend that applicants submit a licensing plan, including pivotal study

protocols, to the CVB for review and comment prior to initiating work that will be

used to support product licensure.

Guidance Documents

A complete listing of the regulations and guidance documents pertinent to

veterinary biologics is found on the CVB's Program Regulations and Guidance page.

We encourage new applicants to read the following documents in particular:

Veterinary Services Memorandum 800.50 

Basic License Requirements and Guidelines for Submission of Materials in Support of

Licensure

Veterinary Services Memorandum 800.101 

U.S. Veterinary Biological Product Permits for Distribution and Sale (guidance

specific to imported products)

Veterinary Services Memorandum 800.73 

(PDF, 350.3 KB)

General Requirements for Immunodiagnostic Test Kits for the Detection of Antibody

or Antigen (guidance specific to diagnostic test kits)

Veterinary Services Memorandum 800.200 

General Licensing Considerations: Study Practices and Documentation

Veterinary Services Memorandum 800.87 

Guidelines for Licensing Establishments with Separated Premises

Veterinary Services Memoranda 
Other "General Licensing Considerations" found in the "800.2XX" series of the

Veterinary Services Memoranda.

Submission Compliance Guide 

(PDF, 1.58 MB)

Submitting Complete and Accurate License Applications, Outlines, and Labels (for

paper submissions only)

Guidance for New Firms

Guidance for Reviewers on Portal Access for New Firms CVB-WI-5233

New Firm Informational Packet for Antivenin Products CVB-WI-5234

New Firm Informational Packet for Cancer Products and Immunomodulatory

Products that Require Client Owned Animals Efficacy and Safety Studies CVBWI-5235

New Firm Informational Packet for Diagnostic Test Kits CVB-WI-5236

New Firm Informational Packet for Live and Inactivated Vaccines Including

Recombinants CVB-WI-5237

Guidance on the NCAH Portal - access is reserved for those firms and/or

products that are close to licensure as determined by the CVB

NCAH Portal Access Information

Training Opportunity

The Institute for International Cooperation in Animal Biologics (IICAB) works to

improve the availability, safety, efficacy and use of veterinary biologics (vaccines

and diagnostics) throughout the world. Veterinary biologics are a cost-effective

method to prevent animal disease, to increase the efficiency of food production, and

to increase the availability of high quality protein for humans. The Institute was

established in 1995 by the USDA Animal and Plant Health Inspection Service and

Iowa State University. The Veterinary Biologics Training Program (VBTP)

provides an overview of the USDA regulatory process for assuring the

purity, safety, potency and efficacy of veterinary biologics (vaccines,

bacterins, antisera, diagnostic kits and other products of biological origin).
Representatives from the USDA Animal and Plant Health Inspection

Service’s (APHIS) Center for Veterinary Biologics (CVB) present

information on the requirements and processes for licensing/registration and

testing of veterinary biological products. The inspection and compliance process for

production, release and post-marketing surveillance of veterinary biological products

is covered in both lectures and workshops. Professionals working in the veterinary

biologics industry, researchers developing biologics, and regulatory personnel are

encouraged to attend and learn about current CVB requirements. This course is a

highly regarded overview of the current regulatory guidelines in the U.S.

The Program is organized by the Institute for International Cooperation in Animal

Biologics (IICAB) and is co-sponsored by the USDA APHIS CVB and the Iowa State

University College of Veterinary Medicine. The Program has been offered annually

from 1996-2019. Over 3000 individuals have attended the program, including 876

international attendees from 96 countries.