U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

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Export Certificates and Certificates of Licensing and Inspection for Animal Biological Products 

1. Purpose and Background 

 

The Center for Veterinary Biologics (CVB) may furnish export certificates for products 

prepared in accordance with the Virus-Serum-Toxin Act and regulations pursuant to the 

Act. This memorandum describes the procedures for processing two types of export 

certifications: Official Export Certificate for Animal Biologics Products, APHIS Form 2017, 

(based on individual batches); and Certificates of Licensing and Inspection, APHIS Forms 

2046, 2046S, 2047, and 2047S (based on the product licensed).

 

2. Document Status 

 

A. Issue Date: 12/09/2021. 

 

B. This document replaces Veterinary Services Memorandum 800.52, dated June 27, 

2018. 

 

3. Reason for Reissuance 

VS is updating this memorandum to clarify the process used for hard copy submissions 

and electronic submissions via the National Centers for Animal Health (NCAH) Portal for 

export documents.

 

4. Authority and References 

 

A. Authorities 

 

• Virus-Serum-Toxin Act (21 U.S.C. 151-159)

• 7 CFR 371.4

• 9 CFR 112.2(e)

• 9 CFR 113.53

 

B. References 

• CVB Biologics Forms: Links to current APHIS forms are provided on the CVB 

Biologics Forms site for ease of access.

• Office of Management and Budget (OMB) Form Disclosure

• All CVB’s forms are part of the OMB information collection package 0579-

0013. All information collections are required to go through periodic renewals 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

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under the Paperwork Reduction Act, 44 U.S.C. 3501 et. seq. During this 

renewal cycle, OMB reviews the forms to ensure they meet the Act’s 

standards and are within the bounds of the information collection description. 

The form’s expiration date is based on the renewal cycle and is unrelated to 

the information in the certificate. 

 

C. Definitions 

1) Export Certificate for Animal Biologics (APHIS Form 2017)- A serial or serials 

(batches)-specific certificate intended for shipment of APHIS-released serials. 

It certifies that products have been manufactured under a U.S. veterinary 

biologics license as prescribed under the Virus-Serum-Toxin Act and 

regulations prescribed under this Act. Further, it indicates that at the time of 

the certificate issuance, the product or products are suitable and freely 

marketed under the conditions stipulated in the license. 

 

2) Certificate of Licensing and Inspection (APHIS Forms 2046, 2047, 2046-S, and 

2047-S - A product license-specific certificate intended for the registration of 

U.S. veterinary licensed products. It certifies that products are manufactured 

under a U.S. veterinary biologics license as prescribed under the Virus-SerumToxin Act and additional regulations prescribed under this Act. Further, it 

indicates that at the time of the certificate issuance, the product or products 

are suitable and freely marketed under the conditions stipulated in the 

license.

 

3) Attestations of good manufacturing practices - A certification that the U.S. 

Veterinary Licensed product complies with the good manufacturing practices 

under a U.S. veterinary biologics license and prescribed under the VirusSerum-Toxin Act. 

4) Ingredients of Animal Origin Certificate - A certification that indicates the 

products comply with the requirements of 9 CFR 113.53 and that by meeting 

all USDA requirements for the use of ingredients of animal origin, the 

establishment will produce licensed veterinary biological products that 

present negligible risk for the transmission of transmissible spongiform 

encephalopathy (TSEs), specifically bovine spongiform encephalopathy, and 

other animal diseases foreign to the United States.

 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

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5. Audience 

VS employees and members of the biologics industry.

 

6. Guidance 

A. Procedures for APHIS Form 2017, Official Export Certificate for Animal Biological 

Products 

1) Portal Submissions

a. NCAH Portal users that meet the following criteria have the opportunity to 

submit APHIS Form 2017 through the NCAH Portal. Users must:

1. Have an USDA eAuthentication Verified Identity account.

2. Have an APHIS 2007 form on file with CVB.

3. Have their eAuthentication username entered into CVB’s Licensing, Serial 

Release, and Testing Information Service (LSRTIS).

4. Be assigned to an active Establishment site in LSRTIS.

5. Have a role of Export Contact, Liaison, and/or Alternate Liaison assigned to 

them in LSRTIS.

b. The NCAH Portal can be found here. There are also links available on the CVB 

NCAH Portal Guidance webpage. Please follow the NCAH Portal User 

guidelines and training videos for the submission of certificates.

2) Hard Copy Submissions

The licensee can also submit an original paper copy of the completed APHIS Form 

2017, Official Export Certificate for Animal Biological Products, to:

Center for Veterinary Biologics

Inspection and Compliance

1920 Dayton Ave

Ames, IA 50010-8197

a. Block 1. Enter the recipient (consignee)’s name and address.

b. Block 2. Enter the shipper (consignor)’s name and address.

c. Block 3. Enter the USDA product code. If more than one product is listed, list

in numerical order based on product code.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

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d. Block 4. Enter the True Name of the product that corresponds to the product

code; do not abbreviate or add additional details to the True Name. If the

destination country requires trade names, list them here, after the True

Name. The trade name option is available in hard copy submissions and upon

request in Portal Submissions.

e. Block 5. Enter the serial number that corresponds to the product code and

product name.

f. Block 6. Enter the number of containers being exported.

g. Block 7. Enter the size of the containers being exported that is most applicable

(doses or milliliter). In the case of diagnostic test kits, choose unit as the

container size.

h. Block 8. Enter the expiration date that corresponds to the serial number listed

in block 5.

i. Block 9. Enter the Veterinary Biologics Establishment License number for the

product listed in block 3.

You may list more than one biological product from the same

establishment number on each form but can only designate one

destination. Fill out Blocks 3 through 9 for each product/serial number

listed. Draw a diagonal line through unused space in blocks 3 through 9.

This informationmust correspond to the information submitted to CVB on an

APHIS Form 2008, Veterinary Biologics Production and Test Report.

Blocks 10 and 11 are optional fields. These fields detail the number ofshipping

boxes and shipping marks(storage temperature or details specific to the

shipment).

Do not include or append additional information to this formand do not submit

handwritten forms.

3) CVB Processing. Compare the completed APHIS Form 2017with the APHIS Form

2008 submitted for the serials listed on the export certificate. 

a. Satisfactory submissions. If there are no discrepancies, CVB numbers, dates,

signs, and embosses the form with the official veterinary biologics seal.

b. Unsatisfactory submissions. If CVB finds discrepancies, it returns the form for

correction. Common reasons for returned submissions are serials not released
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

5 | Page

by CVB forsale and distribution, or incorrect information.

c. Disposition. After completion, CVB retains copies and returns the original to

the licensee. 

B. Procedures for APHIS Forms 2046, 2046s, 2047, And 2047s, Certificates of Licensing 

and Inspection 

1) Types - The submission of Certificates of Licensing and Inspection (CLI) can be

conducted through the NCAH Portal or through hard copy submissions. 

2) NCAH Portal Submissions- English and Spanish language variations of the CLIs for

restricted or non-restricted product are available via the NCAH Portal. NCAH

Portal users mustmeet the same criteria listed in Section 6.A.1)a.

Follow the NCAH Portal User Guides and training videos to submit electronic

certificates. Using the table below, select the appropriate formto comply with

requirements of the country of destination. If you need a Spanish-language

certificate, also submit an accurate, complete English translation for reference.

 

APHIS Form Product License Language

2046 Unrestricted English

2046S Unrestricted Spanish

2047 Restricted English

2047S Restricted Spanish

3) Hard Copy CLI submissions- Required Information. Typically, certificates reflect

the most current establishment and product license information. If you prefer

original licensing information,request this preference in a cover letter

accompanying the hard copy certificates. Only paper copy submissions can list the

original licensing information in the CLI (block 3 and block 7).

a. Block 1. Enter the manufacturer’s name and address. You may include

additional descriptions such as “Formerly Known As”, “Manufacturing Plant”,

or “Doing Business as Firm X.”

b. Block 2. Enter the U.S. Veterinary License Number (Establishment License).

c. Block 3. Enter the date CVB issued the Establishment License.

d. Block 4. Enter the True Name of the product as noted on the product license.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

6 | Page

Do not abbreviate or add additional information. Spanish true names must be

entered as listed on labels filed with CVB.

e. Block 5. Enter the manufacturer’s trade name. The trade name must appear

exactly as on an approved label that is on file with CVB. Provide the assigned

APHIS label number in the accompanying cover letter that contains the listed

trade name. If this field is not used, draw a diagonal line through block 5.

f. Block 6. Enter the USDA product code number, as listed on the product

license.

g. Block 7. Enter the date the CVB issued the product license.

h. APHIS Forms 2047 and 2047S require additional information. The restrictions

included on the certificate must appear exactly as listed on the product

license. List only one biological product on each form for products with

restrictions. Draw a diagonal line through unused space in blocks 4 through 7.

4) Additional or Appended Information

a. List a destination country in the empty space next to the signature block. Do

not list any other information.

b. If the destination country requires additional details such as dose composition

information or copies of labels or circulars, append these to the certificate.

The information appended for certification must be already available in

Outlines of Production or Special Outlines on file with CVB and it must be

current. Product labels or circulars must also include their corresponding

APHIS label number. Use only labels in “Active” status. You may append

diluent labels with the required information on the page.

c. Appended informationmust include page numbers formatted to include

“Page X of Y,” to ensure the that CVB can identify the submission if pages are

separated. This information must be consistent for all pages of the

submission.

d. Include specific requests, such as statements regarding ingredients of animal

origin and/or attestations of manufacturing practices to comply with the

destination country’s registration requirements, in a cover letter. Submit the

request and completed certificates to CVB-Inspection and Compliance at the

address indicated in Section A.2) of this memorandum. Submit attestations

and ingredients of animal origin statements as CLI-appended documents.

However, you may request certification for these as standalone documents.
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

7 | Page

e. A cover letter submitted with the certificate informs CVB of specific requests

and details in reference to the submission. Submitters may also include

shipping labels to provide alternative and traceable returns of certificates.

Specify the certificates to be returned with the specific shipping label. Do not

submit handwritten forms or double-sided pages.

5) CVB Processing

a. CVB assigns a certificate number and signs, dates, and embosses the

requested pages with the official veterinary biologics seal on certificates

verified by information in CVB files. CVB places the embossed seal and the

certificate number on each single page certificate and on multi-page

certificates but will only sign those pages bearing a signature line. All export

documents reviewed and found sufficient, regardless of submissionmethod,

will be printed and processed. CVB returns a hard copy to the submitter or

destination indicated in the request.

b. The NCAH Portal provides the status of electronic submissions only. An email 

will be sent with updates for completed NCAH Portal submissions. The CVB 

response files in the NCAH Portal provide copies of the processed certificate 

in a portable document format (pdf) file. CVB maintains electronic copies of 

portal submissions. Completed submissions will be visible in the NCAH Portal 

for up to sixty (60) days past the date of completion. 

c. For hard copy submissions, CVB retains a copy of the signed certificate for its

files and returns the original to the requester. 

7. Implementation/Applicability 

Updated policy in this memorandum is effective immediately.

Appendices

 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

8 | Page

Appendix I 

Official Export Certificate for Animal Biological Products 

 

 

 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

9 | Page

 

Appendix II 

Certificate of Licensing and Inspection (Non-Restricted Product) 

 

 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.52 

 

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Appendix III 

Certificate of Licensing and Inspection (Restricted Product)