An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 22-08

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron E. Rippke

Director

SUBJECT: Review of Labels for Use in Countries that are Members or Observers of 

the Veterinary International Conference on Harmonization

I. PURPOSE 

The purpose of this Notice is to inform licensees and applicants that the Center for 

Veterinary Biologics (CVB) is exercising regulatory discretion and allowing United 

States Department of Agriculture (USDA) licensed manufacturers to bypass the normal 

label review for labeling used on products destined for Veterinary International 

Conference on Harmonization (VICH) member or observer countries. This policy will 

result in savings and efficiency for both CVB and the regulated industry without any 

expected untoward effects. 

II. BACKGROUND

The CVB currently reviews all labels used on USDA licensed veterinary biologics to 

ensure labels comply with the regulations and do not contain false or misleading 

information. The authority to conduct this regulatory oversight is outlined in title 9, 

Code of Federal Regulations (CFR), part 112. Labels designed for veterinary biologics 

being exported to countries other than the United States are included in the review 

process. In response to input from veterinary biologics manufacturers, CVB reviewed 

its policy regarding international labels. CVB is aware that other countries’ regulatory 

authorities require similar label reviews through interactions with those authorities. 

Since VICH member and observer countries conduct thorough product and label 

reviews prior to allowing U.S. manufactured products to be marketed in their countries, 

CVB is exercising regulatory discretion and allowing USDA licensed manufacturers to 

bypass the normal label review for labeling used on products destined for VICH 

member or observer countries. 

III. ACTION (or POLICY)

A. Eligibility. The countries for which label review is eligible to be discontinued 

include: 

1. VICH Members: European Union (EU) and Japan. 

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS NOTICE 22-08

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 An Equal Opportunity Provider and Employer

2. European Economic Area (EEA) countries when included in EU registrations: 

Iceland, Liechtenstein, and Norway.

3. VICH Observers: Australia, New Zealand, and South Africa. 

Canada’s regulators have requested not to be included in this proposal to maintain 

participation in the web-based product summary postings, see section D below. 

4. The United Kingdom

5. Switzerland, when included in or recognizing an EU registration.

B. To request discontinuation of label review in eligible countries: 

1. Submit a formal request to CVB to discontinue submissions of export-only labeling for 

the specific region (EU) and/or eligible countries (section A. above). Include affected 

product code numbers. 

a. Requests for countries other than those in the EU will only be granted as countryspecific for all products manufactured by the firm for a given eligible country. 

b. The request is only relevant to export-only labeling for products that are not distributed 

to any additional countries. 

2. Prior to making a request, a firm should consider aspects such as Certificates of Licensing 

and Inspection (CLI) or Export Certificates. No Export Certificates (APHIS Form 2017) will 

be issued for countries with a labeling submission exemption. If a firm requests a CLI for a 

country with a labeling submission exemption, the firm must include the following 

statement on the CLI: 

“ATTENTION: The Center for Veterinary Biologics has not reviewed the export labeling 

of this product. Label claims should be reviewed and approved by the importing country 

to ensure accuracy.” 

C. CVB Approval. 

After reviewing the request, CVB will provide written authorization for the firm to 

discontinue submission of export-only labeling for the specific eligible countries deemed 

acceptable. CVB may request additional information. Firms must add a statement indicating 

the Mail Log number with the approved exemption and the applicable countries in Section 

VI.D of the Outline of Production prior to the approval taking regulatory effect. Alternatively, 

firms may create a Special Outline which includes this information and reference the Special 

Outline in Section VI.D of the Outline of Production. Include with this submission a cover 

letter which lists label numbers that will be inactivated. Once the Outline of Production is 

filed, firms will have a transition period of six months to use remaining stocks of previously 
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 An Equal Opportunity Provider and Employer

approved, printed labeling, but may not print additional quantities. At the end of the six-month 

period, previously approved labeling will be inactivated in CVB records.

D. Labeling requirements.

Eligible export-only labeling must not bear the firm’s U.S. Veterinary Biologicals 

Establishment License Number or Product Code Number, and the exporter cannot otherwise 

represent the product labeling in any manner as having met the requirements for USDA 

approval. The labels must not reference the “productdata.aphis.usda.gov” website. 

E. Maintain Records. 

The firm is responsible for maintaining records of all such labeling for export, as per 9 CFR 

116.8. Files and traceability are subject to USDA inspection. 

F. Compliance. 

If a firm is found noncompliant with the policy as stated by including non-eligible country 

labels, requesting and using certifications for countries with no label review, or keeping 

incomplete records, CVB approval for non-submission of export-only labeling could be 

revoked. 

G. Communication. 

CVB will inform the VICH participating countries of this change in policy. 

IV. Implementation/Applicability 

Updated policy in this Notice is effective immediately and will be incorporated into VS 

Memorandum 800.54 at its next revision.