FDA 3613b Supplementary Information Certificate of a Pharmaceutica

Form Approved: OMB No. 0910-0498; Expiration Date: 4/30/2024

Department of Health and Human Services
Food and Drug Administration

SUPPLEMENTARY INFORMATION
CERTIFICATE OF A PHARMACEUTICAL PRODUCT

Send the Export Certificate Requests and supporting documents to the appropriate Center within FDA that would have
control over your product:
CBER: CBER regulates biological products, including blood and blood products, vaccines, allergenics, tissues, and
cellular and gene therapies. CBER also regulates the medical devices involved in the collection, processing, testing,
manufacture and administration of licensed blood, blood components and cellular products and all HIV test kits used
both to screen donor blood, blood components, and cellular products and to diagnose, treat, and monitor persons with
HIV and AIDS. Please apply for your application using https://www.access.fda.gov/oaa. Please see page 5 for CBER
instructions on how to apply for this certificate.
CVM: Feed/food, drugs and devices used in pets, farm animals, and other animals are regulated by the Food and
Drug Administration, Center for Veterinary Medicine, Division of Compliance (HFV-234), 12225 Wilkins Avenue,
MPN4 #133, Rockville, MD 20852. Please email [email protected]. Please see page 6 for
CVM instructions for applying and filling out this form.
1. Requestor Information
Name

Address

Firm

Telephone number

FAX number

Firm Tax ID code

Email address

2. Section 1.0
Proprietary name
Dosage form

3. Section 1.1
Active ingredient
Amount per unit dose

Is the product currently marketed in the United States?
Yes

No

Note: The information for this section may be provided in the approved product labeling and may be attached to the certificate. Attachments are limited to
a total of 10 pages for CBER and CVM. For CVM paper certificate requests for more than one country, provide a copy of the attachments for each
country.

4. Billing and Shipping Account Information
Is the Billing Contact and Address the same as the applicant?
Yes

No

If no, please provide Billing Contact, Email address and Address below.
Address

Billing contact name

Alternate Billing Email Address (if not the same as requestor)
Mail carrier name

Account number and/or Shipping Label

CBER instructions are on page 5.
FORM FDA 3613b (1/23)

CVM instructions are on page 6.
Page 1 of 6

PSC Publishing Services (301) 443-6740

EF

5. Section 2A.1 - 2A.6: Approved Pharmaceutical Product

FDA product approval (BLA/STN, NADA, ANADA, NDA) (Enter either FDA Approval, Submission, License or New
Drug Application Number, as applicable)
Product-license holder

Date of issue (mm/dd/yyyy)

Address

Status of product license holder (mark appropriate item(s))

Manufacturer

Packager and/or Relabeler

Neither

6. Section 2B.1 - 2B.3: Other Pharmaceutical Product
Applicant name

Address

Status of applicant (mark appropriate item(s))
Manufacturer

Packager and/or Relabeler

Neither

For CVM unapproved biological
drugs, mark the category that
indicates why authorization is
lacking (mark appropriate item(s))

Not required

Not requested

Under consideration

Refused

7. Facilities Involved in the Manufacturing of the Exported Product (A maximum of four facilities may be listed for CBER and CVM.)
Facility name (1)

Address

License number (if applicable)
Firm FDA Registration Number

Date of most recent inspection

Facility name (2)

Address

License number (if applicable)
Firm FDA Registration Number

Date of most recent inspection

Facility name (3)

Address

License number (if applicable)
Firm FDA Registration Number

Date of most recent inspection

Facility name (4)

Address

License number (if applicable)
Firm FDA Registration Number

Date of most recent inspection

Do you want the manufacturing location(s) listed on the certificate?
Yes

FORM FDA 3613b (1/23)

Page 2 of 6

No

8. Importing Countries (list in columns)

9. Number of certificates requested:
FORM FDA 3613b (1/23)

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Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“CERTIFICATE OF A PHARMACEUTICAL PRODUCT”
for CBER and CVM

FIRM NAME

As a responsible official or designee authorized to represent and act on behalf of the facility named immediately above, I
hereby certify to the Food and Drug Administration (FDA) that the facility(s) and the products identified on the
Supplementary Information are to the best of my knowledge in substantial compliance with the Federal Food, Drug, and
Cosmetic Act (the Act) and all applicable or pertinent regulations including the following:
1. All facilities that appear on the certificate are currently registered and each facility has listed each of its products
identified for export as required by Section 510 of the Act and 21 CFR Part 207 or 607;
2. Each product(s) identified for export is legally marketed within the United States and is the subject of a Biologics
License, NDA,or ANDA;
3. Each product(s) identified is not subject of an open recall or the subject of any current enforcement action initiated
by FDA;
4. All manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process have been
identified on the 3613b form;
5. The requesting facility and all facilities involved in the manufacturing process are operating in substantial
compliance with Good Manufacturing Practices Regulation for the identified product(s); and
6. Each product(s) identified for export is being exported from the United States
I hereby make this certification of compliance statement for FDA with full knowledge that the making or submission of
false statements represent violations of the United States Code Title 18, Chapter 47, Section 1001. Penalties include up to
$250,000 in fines and up to five years imprisonment.
SIGNATURE

DATE

NAME AND TITLE

Making or submitting false statements on any documents submitted to FDA may constitute violations of the
United States Code Title 18, Chapter 47, Section 1001 with penalties including up to $250,000 in fines and up
to 5 years imprisonment.
FORM FDA 3613b (1/23)

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Department of Health and Human Services
Food and Drug Administration

EXPORT CERTIFICATION

Submission Requirements for Requesting Certificates for
Exporting Products to Foreign Countries (for CBER)
Background
Firms exporting products from the U.S. are often asked by foreign
customers or foreign governments to supply a certification relating
to products subject to the Federal Food, Drug, and Cosmetic Act and
other acts the Food and Drug Administration (FDA) administers.
Under the FDA Export Reform and Enhancement Act of 1996
(the Act), FDA is authorized to issue certifications for drugs, animal
drugs, and devices within 20 days of receipt of a request for such a
certificate. A fee of up to $175 may be charged for each export
certification issued.

• Questions may be directed to the Import/Export Team at CBERBE
[email protected].
• Request an Export Certificate using one of the following methods.
To facilitate your certificate request, please apply for your
application using https://www.access.fda.gov/oaa. Create a new
account and select the Biologics Export Certificate Application
and Tracking System (BECATS). If you have any problems, then
please contact us at HYPERLINK “mailto:CBERBECATS@fda.
hhs.gov” ([email protected]). You may also send the
request and supporting documents to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
10903 New Hampshire Ave.
Building 71, Room G112
Silver Spring, MD 20993-0002

General Instructions:
• The “Certificate of a Pharmaceutical Product” is an export
certification that conforms to the format established by the World
Health Organization (WHO) and is intended for use by the
importing country when the product in question is under
consideration for a product license that will authorize its
importation and sale or for renewal, extension, amending or
reviewing a license. WHO Certificate requests should include the
information listed in Supplementary Information – Certificate
of a Pharmaceutical Product Requests (PDF, Text). Please
ensure that the Exporter’s Certification Statement is signed by a
responsible official of the exporting firm and is enclosed with the
certificate request. Enclose labels for each product.
• Please type certificate requests or print clearly.
• In most cases, one product will be listed per certificate. However,
products that were approved under the same application may be
listed on the same certificate based on the available space for a one
page certificate. Certificate requests for listing multiple products
will be evaluated on a case-by-case basis.
• If information is omitted in the application by the requestor or if
clarification is needed on the supplied information, the requestor
will be contacted. If the requestor does not provide the necessary
information within 48 hours, the request for certificates will be
returned and will need to be resubmitted for FDA review.

FORM FDA 3613b (1/23)

• On October 1, 1996, CBER was given the authority to charge $175
for the first two certificates and $85 for any subsequent certificates
issued for the same product(s) in response to the same certificate
request. Please do not submit a check with your request, as FDA
will bill you quarterly for issued certificates.
• Errors made by FDA during the preparation of export certificates
will be corrected, at no cost to the applicant, within 45 days after
issuance.
– Errors made in the application, by the submitter, cannot be
corrected. A new application must be submitted.
• You may enclose a completed air billing number and mailing
supplies to expedite the return of Certificates.
Issuance of a “Certificate to Foreign Government”, “Certificate
of Exportability” or “Certificate of a Pharmaceutical Product”
will not preclude regulatory action by FDA, if warranted, against
products covered by the Certificate.

Page 5 of 6

Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR COMPLETION OF
APPLICATION FOR CERTIFICATES
(for CVM)
1. The “Certificate of a Pharmaceutical Product” conforms
to the format established by the World Health Organization
(WHO) and is intended for use by the importing country when
the product in question is under consideration for a product
license that will authorize its importation and sale or for renewal,
extension, amending or reviewing a license. WHO Certificate
requests should include the information listed in Supplementary
Information – Certificate of a Pharmaceutical Product
Requests. Please ensure that the Exporter’s Certification
Statement is signed by a responsible official of the exporting firm
and is enclosed with the certificate request. Enclose labels for
each product.
2. If the requested information on the application form is not
provided by the exporting firm or if clarification is needed on
the supplied information, the exporting firm will be contacted
via telephone. If the exporting firm does not provide the
necessary information within 48 hours, the request for certificates
will be returned and will need to be resubmitted. You may enclose
a completed UPS form and mailing supplies to expedite return of
the Certificates. A certificate will be issued for each product.

3. Requests for certificates should be sent to:
Food and Drug Administration
Center for Veterinary Medicine
Division of Compliance (HFV-234)
12225 Wilkins Avenue, MPN4 #133
Rockville, MD 20852
[email protected] – for inquiries)
4. Errors made by FDA during the preparation of export certificates
will be corrected, at no cost to the applicant, within 45 days after
issuance.
• Errors made in the application, by the submitter, cannot be
corrected. A new application must be submitted.
5. The fee for preparing and issuing a single certificate is $175; 1st
duplicate original $155; and $70 for each subsequent duplicate.
Please do not include the fee payment with your requests; the
exporting firm will be billed quarterly.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 1 hour per response, including the time to review
instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of
information. Send comments regarding this burden estimate or any other aspect of this information collection, including
suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3613b (1/23)

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