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NEW JERSEY DEPARTMENT OF HEALTH
Consumer, Environmental and Occupational Health Service
Public Health & Food Protection Program
http://nj.gov/health/ceohs/food-drug-safety/cert-free-sale
Phone: (609) 826-4935
Guidelines for Requesting Certificates of Free Sale
GMP Certificates, Health Certificates, Export Certificates, Sanitation Letters
Contents
Eligibility and Who May Apply ................................................................................................................................................ 2
Certificates of Free Sale .......................................................................................................................................................... 2
Request for Certificates of Free Sale ....................................................................................................................................... 2
Product GMP Certificates, Export Certificates and Health Certificates .................................................................................. 3
General GMP Certificates and Sanitation Letters ................................................................................................................... 4
Frequently Asked Questions ................................................................................................................................................... 4
How long is the review process?......................................................................................................................................... 4
Who will sign and notarize my certificate? ......................................................................................................................... 4
What are Notary Public signatures, Apostilles and Notary Certifications? ........................................................................ 4
Optional Service: Apostilles and Notary Certifications ........................................................................................................... 5
NJ Department of the Treasury, Division of Revenue ......................................................................................................... 5
As a Courtesy: Forwarding of Completed Documents to the Division of Revenue for Further Certification ................. 5
Mercer County Clerk’s Office .............................................................................................................................................. 6
As a Courtesy: Forwarding of Completed Documents to the Mercer County Clerk for Further Certification ............... 6
Hand-delivered applications will not be accepted. All applications must be submitted via USPS or courier.
Submissions via United States Postal Service Only
NJ Department of Health
Certificates of Free Sale
P.O. Box 369
Trenton, NJ 08625
Submissions via UPS or FedEx Only
NJ Department of Health
Certificates of Free Sale
135 East State Street
Trenton, NJ 08608
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Eligibility and Who May Apply
Certificates of Free Sale and all related certificates and letters generated by the Department of Health (DOH) are
available only to applicants that meet all of the following criteria:
1. The applicant must operate a business facility in New Jersey.
2. The applicant’s New Jersey facility must operate as a warehouse or manufacturing facility for food, cosmetic, drug, or
medical device products.
3. The applicant’s New Jersey facility must have passed a sanitary inspection by DOH or by the US Food and Drug
Administration with a Satisfactory rating.
4. The applicant must hold a New Jersey Wholesale Food-Cosmetic or Wholesale Drug-Medical Device registration that is
current and in good standing.
5. The products to be listed on the certificate must be food, cosmetics, drugs or medical devices physically manufactured
or stored in the applicant’s registered and inspected New Jersey facility.
A third-party distribution or brokering company may apply for a certificate only if the source of products complies with
the above criteria. A third-party applicant is responsible for notifying the source facility of an intention to apply for a
certificate and for obtaining the license number and date of inspection directly from the source facility.
Certificates of Free Sale
A Certificate of Free Sale is defined as a certificate completed and issued by DOH attesting that a specific food, drug,
cosmetic or medical device product regulated under Title 24 of the New Jersey Statutes and manufactured, distributed,
and offered for sale in this State is labeled in conformance with the applicable food, drug, cosmetic or medical device
laws.
Certificates of Free Sale are required by many foreign countries in order to receive food, cosmetic, and drug imports.
The certificates certify that a company is in substantial compliance with the State and Federal standards and that the
products being exported are equivalent to products marketed domestically in the United States.
Request for Certificates of Free Sale
Certificates of Free Sale are written by the applicant and signed and notarized by DOH. The following forms and
attachments must be included with your request:
1. Application Form
The first page of form number F-L3, Certificate of Free Sale Package, must be completed in its entirety. One
application form may be used to request multiple certificates. The Certificate of Free Sale Package (form F-L3) may be
found at the following webpage: http://nj.gov/health/ceohs/food-drug-safety/cert-free-sale
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2. Certificate of Free Sale
The second page of form number F-L3 is the Certificate of Free Sale. Follow the numbered instructions on the
application form to fill in the certificate. Each original certificate you submit will be reviewed, signed and notarized by
DOH. Each original certificate must be a one-sided, one-page document with a minimum of 8-point Arial font. Each
certificate may list a maximum of 25 products. Product names may be separated by line, by column or by comma.
Additional information such as invoice numbers, product information and shipment destination are acceptable but not
required by this office.
3. Labels
Each product listed on the certificate must be accompanied by a corresponding original, legible label or label graphic
as it appears on the product packaging for final sale to the consumer. If the original final label is in a language other
than English, please also provide the English translation of each label. For bulk ingredients that are not labeled for final
sale, a Certificate of Analysis is acceptable for each product in lieu of a label.
4. Return Postage
Submit a stamped, self-addressed envelope for the return of your completed certificates. To expedite mailing and to
provide tracking capability, you may instead include a prepaid courier shipping label showing the customer as the
sender and bill-to party. Please note that return labels provided for FedEx shipping should be marked for “FedEx
Express.” Shipping labels marked FedEx Ground will not be accepted.
5. Check or Money Order
One check or money order may be submitted for multiple certificate requests. Checks or money orders should be
made payable to NJ Department of Health. Credit card payments are only accepted through the DOH online payment
system and must be prepaid before submission: http://nj.gov/health/ceohs/food-drug-safety/epayments.shtml
Product GMP Certificates, Export Certificates and Health Certificates
Product GMP, Export, and Health Certificates are written, signed and notarized by DOH. The following forms and
attachments must be included with your request:
1. Application Form
Form number F-12, Application for Certificate of Free Sale, maybe utilized to request Product GMP, Export, and Health
Certificates. One application form may be used to request multiple certificates. The application form F-12 may be
found at the following webpage: http://nj.gov/health/ceohs/food-drug-safety/cert-free-sale
2. Product List
On an otherwise blank sheet of paper, provide a typed list of the exact names of the products as you would like them
to appear on each certificate. Each certificate may list a maximum of 25 products. Products may be separated by line,
by column or by comma. Additional information such as invoice numbers, product information and shipment
destination are acceptable but not required by this office.
3. Labels
Each product listed on the certificate must be accompanied by a corresponding original, legible label or label graphic
as it appears on the product packaging for final sale to the consumer. If the original final label is in a language other
than English, please also provide the English translation of each label. For bulk ingredients that are not labeled for final
sale, a Certificate of Analysis is acceptable for each product in lieu of a label.
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4. Return Postage
Submit a stamped, self-addressed envelope for the return of your completed certificates. To expedite mailing and to
provide tracking capability, you may instead include a prepaid courier shipping label showing the customer as the
sender and bill-to party. Please note that return labels provided for FedEx shipping should be marked for “FedEx
Express.” Shipping labels marked FedEx Ground will not be accepted.
5. Check or Money Order
One check or money order may be submitted for multiple certificate requests. Checks or money orders should be
made payable to NJ Department of Health. Credit card payments are only accepted through the DOH online payment
system and must be prepaid before submission: http://nj.gov/health/ceohs/food-drug-safety/epayments.shtml
General GMP Certificates and Sanitation Letters
General GMP Certificates and Sanitation Letters are written, signed and notarized by DOH. They are general statements
and do not include a product list. The following forms and attachments must be included with your request:
1. Application Form
Form number F-12, Application for Certificate of Free Sale, maybe utilized to request General GMP Certificates and
Sanitation Letters. One application form may be used to request multiple certificates. The application form F-12 may
be found at the following webpage: http://nj.gov/health/ceohs/food-drug-safety/cert-free-sale
2. Return Postage
Submit a stamped, self-addressed envelope for the return of your completed certificates. To expedite mailing and to
provide tracking capability, you may instead include a prepaid courier shipping label showing the customer as the
sender and bill-to party. Please note that return labels provided for FedEx shipping should be marked for “FedEx
Express.” Shipping labels marked FedEx Ground will not be accepted
3. Check, Money Order, or Proof of Online Payment
One check or money order may be submitted for multiple certificate requests. Checks or money orders should be
made payable to NJ Department of Health. Credit card payments are only accepted through the DOH online payment
system and must be prepaid before submission: http://nj.gov/health/ceohs/food-drug-safety/epayments.shtml
Frequently Asked Questions
How long is the review process?
Please allow ten (10) working business days from the time your request is received by DOH for processing and review.
This period does not include processing time for Apostilles and Notary Certifications, if requested.
DOH does not offer expedited service.
Who will sign and notarize my certificate?
All certificates will be signed and notarized by DOH staff. A Notary Public signature is included with all certificate
requests. Do not sign or notarize the Certificate of Free Sale yourself.
What are Notary Public signatures, Apostilles and Notary Certifications?
A Notary Public’s signature attests to the identity of the person signing a document. An Apostille or Certification of
Good Standing for Notaries Public is an additional document completed by NJ Department of the Treasury, Division of
Revenue, or the Mercer County Clerk’s Office that attests to the legal status of the Notary Public.
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Optional Service: Apostilles and Notary Certifications
The remainder of this guide refers to optional services offered by separate departments. The following information is not
applicable to most documents. Please check with the country of destination for document requirements.
Apostilles and Notary Certifications certify the good standing of the signing DOH Notary Public. This optional service
may be required by some countries as an additional attachment to a completed and notarized certificate. Most
documents do not require an apostille or notary certification.
Apostilles and Notary Certifications are completed by the New Jersey Department of the Treasury, Division of Revenue.
Notary Certifications may also be completed by the Mercer County Clerk’s office. Both agencies are entirely separate
from the Department of Health. Completed certificates that require an apostille or notary certification must be
forwarded to a separate office for separate processing after the initial certificate process is complete.
NJ Department of the Treasury, Division of Revenue
The information provided below is subject to change by the NJ Department of the Treasury. For current information and
application forms for apostilles and notary certifications, please visit the NJ Department of the Treasury, Division of
Revenue website: http://www.state.nj.us/treasury/revenue/apostilles.shtml
Any completed, notarized document may be submitted by the customer directly to NJ Department of the Treasury,
Division of Revenue, for an apostille or notary certification (not to be confused with a notary signature: please see the
FAQ above). It is not required to be submitted directly from DOH. As a courtesy and upon receipt of appropriate
documents, DOH will forward your completed certificates directly to the Division of Revenue on your behalf.
As a Courtesy: Forwarding of Completed Documents to the Division of Revenue for Further Certification
To request DOH to forward your documents to the Division of Revenue upon completion, please enclose the following in
addition to the application package:
1. Application Form
Enclose the completed Apostille/Certificate of Authentication Request Form, which is provided by the Division of
Revenue. The application form is available for download at the following website:
http://www.state.nj.us/treasury/revenue/apostilles.shtml
2. Check or Money Order, if applicable
If you will be paying for the apostille or notary certification with a check or money order, enclose a separate fee
according to the instructions on the application form provided by the Division of Revenue.
3. Courier Shipping Label (required)
Submit a shipping label showing the customer as the sender and bill-to party to be used by DOH to forward the
completed, notarized certificates to the Division of Revenue, which is located in a separate building. DOH will not
provide postage to forward documents to the Division of Revenue. If a shipping label is not included, the completed
and notarized documents will be sent back to you directly. You may submit the completed original documents to the
Division of Revenue at any time. The shipping address of the Division of Revenue is as follows:
NJ Division of Revenue and Enterprise Services
Attn: Notary Unit
33 West State Street, 5
th
Floor
Trenton, NJ 08608
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Mercer County Clerk’s Office
The information provided below is subject to change by the Mercer County Clerk’s Office. For current information
regarding notary certifications, please visit the Mercer County Clerk’s Office website:
http://nj.gov/counties/mercer/officials/clerk
Any completed, notarized document may be submitted by the customer directly to the Mercer County Clerk’s Office for
a notary certification (not to be confused with a notary signature: please see the FAQ above). It is not required to be
submitted directly from DOH. As a courtesy and upon receipt of appropriate documents, DOH will forward your
completed certificates directly to the Mercer County Clerk’s Office on your behalf. Please note that the Mercer County
Clerk’s Office processes certifications of good standing for Notaries Public only. Please refer to the country of
destination for certificate requirements.
As a Courtesy: Forwarding of Completed Documents to the Mercer County Clerk for Further Certification
To request DOH to forward your documents to the Mercer County Clerk’s Office upon completion, please enclose the
following in addition to the application package:
1. Letter of Request
Enclose a letter addressed to the Mercer County Clerk. State the number of requested Certificates of Good Standing
for Notaries Public, the name of the company stated on the certificates, and the name and phone number of a contact
person for any questions.
2. Check or Money Order
Enclose a separate check or money order made payable to Mercer County Clerk. There is a $5.00 fee for each
certificate of good standing.
3. Stamped Envelope or Courier Shipping Label (required)
Submit a stamped, addressed envelope or a shipping label showing the customer as the sender and bill-to party to be
used by DOH to forward the completed, notarized certificates to the Mercer County Clerk’s Office, which is located in
a separate building. DOH will not provide postage to forward documents to the Mercer County Clerk’s Office. If
forwarding postage is not included, the completed and notarized documents will be sent back to you directly. You may
submit the completed original documents to the Mercer County Clerk’s Office at any time. The shipping address of the
Mercer County Clerk’s Office is as follows:
Submissions via US Postal Service Only: Submissions via UPS or FedEx Only*:
Paula Sollami Covello, Esq. Paula Sollami Covello, Esq.
Mercer County Clerk Mercer County Clerk
P.O. Box 8068 240 West State Street
Trenton, NJ 08650 Trenton, NJ 08608
*The UPS/FedEx address for the Mercer County Clerk is subject to change. Please refer to the website for up-to-date
information: http://nj.gov/counties/mercer/officials/clerk
