FDA 3613b SUPPLEMENTARY INFORMATION CERTIFICATE OF A PHARMACEUTICA

Form Approved: 0MB No. 0910-0498; Expiration Date: 8/31/2021

SUPPLEMENTARY INFORMATION
CERTIFICATE OF A PHARMACEUTICAL PRODUCT

Department of Health and Human Services
Food and Drug Administration

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 oflicensed 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_ofCompliance (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.
No Changes

Telephone number

Address

Firm Tax ID code

FAX number

and National Drug Code if available

.

.

Email address

. .· ..

'-.--

Active ingredient
Amount per unit dose

Is this product currently marketed in the United States?

D Yes D No

Is the product licensed/approved to be placed on the market in the U.S.?

D Yes D 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.

Billing and Shipping Account Information

No Change

Is the Billing Contact and Address the same as the applicant?

Billing contact name

□ No

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

Address

Alternate Billing Email Address (if not the same as requestor)
___________

Fedex or UPS label

Phone number:
______________________________
Account number and/or Shipping Label

CBER instructions are on page 5.

FORM FDA 3613b (2/19)

Fax number:

CVM instructions are on page 6_

Page 1 of 6

PSC Publishing Scn·ices (301) 443-6740

EF

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 (mmlddlyyyy)
CVM will ask for date of
approval instead

Address

D Manufacturer

Status of product license holder (mark appropriate it�m(s))

D Packager and/or Relabeler

D Neither

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

Address

Status of applicant (mark appropriate item(s))

D Manufacturer
D Neither

D Packager and/or Relabeler

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

CVM will no longer ask

D Not required
D Under consideration

D Not requested
D Refused

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
Firm Establishment Identifier (FEI)

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
Do
you want the manufacturing tocation(s) listed on the certificate?
-----------------------------------------------------------------

FORM FDA 3613b (2/19)

Date of most recent inspection

D
Page 2 of 6

□

CVM will no longer ask
Yes

No

8. Importing Countries (list in columns)

No Changes

9. Number of certificates requested:

No Changes

FORM FDA 3613b (2/19)

Page 3 of 6

Department of Health and Human Services
Food and Drug Administration

EXPORTER'S CERTIFICATION STATEMENT
"CERT/FICA TE 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
Application 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 Application are cmrently registered and each facility has listed each of its products
identified for expo1t as required by Section 510 of the Act and 21 CFR Pait 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 Application;
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

SIGNATURE

DATE

NAME AND TITLE

I hereby m�ke 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.
FORM FDA 3613b (2/19)

Page 4 of 6

Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR COMPLETION OF
APPLICATION FOR CERTIFICATES
(forCVM)
1. The "Certificate of a Pharmaceutical Product" conforms
to the formal 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 Pmduct
Requests. Please ensure that the Exporter's Ce1tification
Statement is signed by a responsible official of the exporting firm
and is enclosed with the ce1tificate 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 infmmation 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 ce1tificates should be sent to:
Food and Drug Administration
Center for Vcterinary Medicine
Division of Compliance (HFV-234)
12225 Wilkins Avenue, MPN4 #I 33
Rockville, MD 20852
[email protected] - for inquiries)
4. Errors made by FDA during the preparation of export certificates
will be corrected, al no cost lo 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 Pape1work Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
The burden time for this collection of infonnation 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:
Depmtment of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff

PRAStafJ@[da.hhs_gov

"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 0MB number. "

FORM FDA 3613b (2/19)

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