FDA 3613f REQUEST FOR CERTIFICATE OF A PHARMACEUTICAL PRODUCT FOR

Form Approved: OMB No. 0910-0498; Expiration Date: April 30, 2024

Department of Health and Human Services
Food and Drug Administration

REQUEST FOR
CERTIFICATE OF A PHARMACEUTICAL
PRODUCT FOR CDER PRODUCTS

GENERAL INFORMATION
Firms exporting drugs from the United States, are often asked by their customers or foreign governments to supply an
export certificate for products regulated by the U.S. Food and Drug Administration (FDA). FDA issues export
certificates for drugs that are approved or licensed by FDA to be marketed in the United States and for over-the-counter
drugs that follow an FDA monograph. FDA also issues export certificates for unapproved drugs that meet requirements
of federal law. The drug export requirements can be found in section 801 and /or 802 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act). The Center for Drug Evaluation and Research (CDER) issues Certificates of Pharmaceutical
Product (CPP) for human drugs that it regulates. CPPs are the only type of export certificate that CDER issues and they
are requested by firms to help them qualify their product for importation into a foreign market or to receive approval,
licensing or registration of the drug abroad. CPPs conform to the format established by the World Health Organization
(WHO) and expire 2 years from the date of issuance.
Electronic CPPs for drugs exported from the U.S. are issued in .pdf document formats. Different ribbon colors are used
to designate the type of CPP issued, as follows:
• Red designates FDA-approved products;
• Purple designates over-the-counter (OTC) products;
• Blue designates unapproved products;
• Yellow designates drugs manufactured in foreign facilities; and
• Orange designates Active Pharmaceutical Ingredients (APIs).
Under Section 801(e)(4)(B) of the FD&C Act, FDA is authorized to charge a fee for CPPs issued within 20 days of
receipt of an application, not to exceed $175.00. The fees are as follows:
• First certificate for the same country in the same application ........................................... $175.00
• Second certificate for the same country in the same application .......................................... 90.00
• Third and subsequent certificates for the same country in the same application .................. 40.00
Invoices are issued quarterly.
Send CPP Requests and supporting documents to the following address:
Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Export Certificate Program,
10903 New Hampshire Avenue, Building 51, Room 4249, Silver Spring, MD 20993-0002.
For inquiries about CPPs, please e-mail [email protected].
For the most current CDER Export Certificate Program information, please visit: https://www.fda.gov/drugs/guidancecompliance-regulatory-information/human-drug-exports
1. Requestor Information
Name

Address

Firm

Telephone number

E-mail address

2. Drug Information
Drug Proprietary name
Dosage form (e.g. capsules, powder, drops)

Instructions begin on page 5.
FORM FDA 3613f (02/23)

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PSC Publishing Services (301) 443-6740

EF

3. Active Ingredient Information
Active ingredient
Amount per unit dose

FDA product listing number (e.g., NDC)

Is the product currently marketed in the
United States?
Yes
No

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 and Address below.

Billing contact name

Address

Firm Tax ID code

5. Drug Marketing Information
FDA drug approval number (ANDA, BLA, NDA) or FDA OTC Monograph citation/title

Date of drug approval or OTC monograph
ruling (mm/dd/yyyy)

Please provide a copy of the drug approval letter.
Also, please note that “licensed drug” refers to a drug with an FDA drug approval number.
Product license holder

Address

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

Manufacturer

Packager and/or Relabeler

Neither

6. Applicant for Certificate Information
Applicant for Certificate

Address

Status of the Applicant for Certificate (mark appropriate item(s))
Manufacturer

Packager and/or Relabeler

Neither

For unapproved drugs and APIs,
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 three facilities and only one drug manufacturer
may be listed per application.)
Facility name (1) and role (e.g., API manufacturer, labeler, drug
manufacturer)

Address

Firm FDA Registration Number (FEI number and/or DUNS number)

Date of most recent inspection
(Item 7 entry sets continued, next page)

FORM FDA 3613f (02/23)

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7. Facilities Involved in the Manufacturing of the Exported Product (Continued)
Facility name (2) and role (e.g., API manufacturer, labeler, drug
manufacturer)

Address

Firm FDA Registration Number (FEI number and/or DUNS number)

Date of most recent inspection

Facility name (3) and role (e.g., API manufacturer, labeler, drug
manufacturer)

Address

Firm FDA Registration Number (FEI number and/or DUNS number)

Date of most recent inspection

8. Importing Countries (List in columns and indicate if multiple copies for a country are needed, please limit to 15 countries per application.)

9. Total number of certificates requested:

FORM FDA 3613f (02/23)

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CERTIFICATION STATEMENTS (Complete all that apply)
EXPORTER’S CERTIFICATION STATEMENT
The information, contained in this request for a Certificate of a Pharmaceutical Product is true and accurate based upon
the current approval or other legal basis permitting marketing of the product. We acknowledge that any false or fictitious
statements made in the application used by FDA to process the certificate will be in violation of the United States Code,
Title 18, Section 1001.
Signature

Date

Name and Title:

AUTHORIZATION TO RELEASE STATEMENT
I authorize the Food and Drug Administration to release this information in the certificate format. I understand that we
will be billed a fee for each certificate not to exceed $175.00. If you have any questions or require additional information
(e-mail
regarding this correspondence, please e-mail me at
address).
Signature

Date

Name and Title:

CERTIFICATION OF EXPORTATION FROM THE U.S. FOR FOREIGN MANUFACTURING SITES
for products manufactured in a country outside of the United States
I certify that

(Product Name)

is manufactured and/or packaged in

(Name of Foreign Country)

and is exported from the United States.
Signature

Date

Name and Title:

CERTIFICATION OF EXPORTATION FROM THE U.S. FOR UNAPPROVED DRUG PRODUCTS
I certify that

(Product Name)

is intended for export and is in compliance with the applicable provisions of section 801(e) and section 802 of the FD&C
Act, as amended by the FDA Reform and Enhancement Act of 1996.
Signature

Date

Name and Title:

FORM FDA 3613f (02/23)

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Department of Health and Human Services
Food and Drug Administration

CERTIFICATE OF A PHARMACEUTICAL PRODUCT
Application Instructions (for CDER)
General Information

CPP Requests for FDA Approved Drugs

• Before preparing your application, please consult with the
importing country to determine exactly what type of information
is required for the certificate.

• Complete Form 3613f (sections 1, 2, 3, 4, 5, 6, 7, 8 and 9).

• A US Tax Code/US Tax number is required to process your
application.

• For drug products under the President’s Emergency Plan for AIDS
Relief (PEPFAR), include a copy of the full or tentative approval
letter.

• The “requestor” is the firm or person filling out the application.
The “applicant” is the firm or person requesting the CPP. For
example, a firm (applicant) may hire another firm (requestor) to
fill out an application on its behalf.

• Provide a copy of the FDA approval letter and/or supplemental
letter.

• You are required to provide the following attachments: FDAapproved container label, package label, and package insert.

• Do not submit applications in binders or place attachments in
plastic sleeves.

• You may include additional documents for attachment such as a
drug formulation page or other information required by the
importing country.
• Complete and sign exporter’s certification statement and
authorization to release statement.

• A separate application must be made for each pharmaceutical
product.

• Complete and sign certification statement for foreign manufacturing
facilities, if applicable.

• Multiple countries for each pharmaceutical product may be
requested in one application.

CPP Requests for OTC Drug Products

• CDER recommends sending your application with confirmation
of delivery receipt to ensure delivery.

• If requesting a CPP with more than one drug manufacturer, please
submit separate applications for each drug manufacturer. You may
include more than one labeler or packager on one application.
• Foreign names for the pharmaceutical products may be included.
• For container labels, please provide the actual label or a copy of
the art layout. The label must be in color and legible. Do not
include bottles or vials with your application.
• For package labels, please provide the actual package container
(collapse box before mounting) or a copy of the art layout. The
label must be in color and legible.
• An API is the bulk drug substance (or raw material) that has not
been processed into a final dosage form (e.g., tablet, capsule).
CDER does not issue CPPs for intermediates or inactive
ingredients (also known as excipients).
• For API CPP requests, the CPP will list the drug’s International
Nonproprietary Name (INN) or National Nonproprietary name.
• Your application may be returned if the manufacturing facility is not
registered and the pharmaceutical product is not listed pursuant to
section 510 of the FD&C Act. Drug listing is required for approved
drugs, OTC drugs, unapproved drugs, bulk APIs, and products for
export only.
• Incomplete applications may be returned.
• FDA will not issue a CPP for products that do not meet the
applicable requirements of the FD&C Act.
• Errors made by FDA during the preparation of CPPs will be
corrected at no cost to the applicant, if requested within 45 days
after issuance.

• Complete Form 3613f (sections 1, 2, 3, 4, 5, 6, 7, 8 and 9).
• You are required to provide the following attachments: container
label that complies with the requirements of the applicable OTC
monograph.
• You may include additional documents for attachment, such as a
drug formulation page or other information required by the
importing country.
• Complete and sign exporter’s certification statement and
authorization to release statement.
• Complete and sign certification statement for foreign manufacturing
facilities, if applicable.

CPP Requests for APIs
• Complete Form 3613f (sections 1, 3, 4, 6, 7, 8 and 9).
• You are required to provide the following attachment: package or
container label that complies with the labeling requirements of 21
Code of Federal Regulations (CFR) 201.122.
• You may include additional documents for attachment, such as a
drug formulation page or other information required by the
importing country.
• Complete and sign exporter’s certification statement and
authorization to release statement.
• Complete and sign certification statement for foreign manufacturing
facilities, if applicable.
• Complete and sign certification statement for unapproved drugs.

• Issuance of a CPP for CDER-regulated drugs will not preclude
regulatory action by FDA, if warranted, against products covered
by the CPP.
FORM FDA 3613f (02/23)

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Certificate of a Pharmaceutical Product – Application Instructions (for CDER) (Continued)

CPP Requests for Unapproved Drugs
• Complete Form 3613f (sections 1, 2, 3, 4, 6, 7, 8 and 9).
• You are required to provide the following attachments: container
label and drug formulation page.
• You may include additional documents for attachment, such as ones
containing other information required by the importing country.
• Complete and sign exporter’s certification statement and
authorization to release statement.
• Complete and sign certification statement for foreign manufacturing
facilities, if applicable.
• Complete and sign certification statement for unapproved drugs.

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FORM FDA 3613f (02/23)

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