A Certificate of Free Sale indicates that a particular product, such as: cosmetics, infant food, dietary supplements, food additives, and medical devices is legally marketed throughout the United States and/or is eligible for export process.
Since 2016, the FDA, US Food and Drug Administration, has launched its new automated system to file for Free Sale Certificate electronically. The FURLS (FDA Unified Registration and Listing System) has shortened the duration of the processing time and helped U.S. export corporations to obtain Certificates of Free Sale timely and effectively.
However, exporters can still order their request by mail. It usually takes about 2-3 weeks and the fee is about $10.00 per certificate for the export of food, food additives and cosmetics; a Certificate of Free Sale for medical devices cost $175.00 per certificate.
The apostille must be obtained from the U.S. Department of State for the federally issued documents.
Federally issued documents destined for use in participating Hague participating countries will need an apostille issued by the U.S. Department of State; and federally issued documents to be used in nonparticipating Hague countries require an authentication certificate issued by the U.S. Department of State. Official federal issued documents are signed by a U.S. Federal Official, an American Consular Officer, a Military Notary Public, a Judge Advocate (10 USC 1044a), or a foreign consul diplomatic official registered with the State Department Office of Protocol.
How to Apostille Certificate of Free Sale
Step One: Request and Receive Your Certificate of Free Sale From CFSAN, an Agency Within FDA
FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. To start the process of interaction with the FDA you will need to create an FDA Industry Systems account.
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Products covered: The FDA provides Certificates of Free Sale (also called Export Certificates) for cosmetics, dietary supplements, infant formulas, medical foods (includes vitamins, minerals, amino acids, herbals), food additives, plant and dairy foods and beverages, seafood, EU (European Union)Animal Health and Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate, human or animal drugs, biologics, and medical devices, although medical devices have some special rules that only apply to them.
Food, Food Additives, Seafood, Dietary Supplements, and Cosmetics (FDA)
Cost: Certificates issued by Center for Food Safety and Applied Nutrition (CFSAN) for food, food additives, seafood, dietary supplements, and cosmetics cost $10. Certificates may take up to 3-8 weeks, depending on how busy the agency is and how varied the business products and methods are. Processing of a certificate cannot begin until all requested documents have been received.
Submit the online application: (select ‘FURLS Certificate Application Process’).
Food Export Certificate Application instructions.
Is my product a cosmetic product?
Human or Animal Drugs, Biologics and Medical Devices (FDA)
Cost: For export certificates, the agency charges a fee of up to $175, if the certificate is issued within 20 government working days from the time a complete request is received. This fee may vary depending on the exported product type, not to exceed $175.
Export of Legally Marketed Medical Devices (FDA)
The FDA allows the export of legally marketed devices, but some countries require written certification that a company or its devices are in compliance with U.S. law. The Certificate of Foreign Government (CFG) is a self-certification process that is produced on special paper with the gold seal, but not verified by the FDA.
Cost: Center for Devices and Radiological Health (CDRH) requires an initial fee of $175 per certificate and $15 per certificate for additional certificates issued for the same product in the same letter of request.
Submit your request for a CFG on form FDA-3613, Supplementary Information Certificate to Foreign Government Requests, page 4. Questions regarding the CFG should be directed to the Office of Compliance, Export Certificate Team, at 301-796-7400 or by email at [email protected] or call Leila Lawrence 240-276-0132.
Export of Unapproved Medical Devices
Certificate of Exportability (COE) was implemented by the FDA to facilitate export of an unapproved medical devices. Exporters applying for a COE are required to sign a statement indicating that they meet four criteria. You will need to go to www.FDA.gov. for more information.
Cost: An initial fee of $175 per certificate and $15 per certificate for additional certificates issued for the same products in the same letter of request. Original certificates will be produced on special paper with the gold seal, and should be ready within 20 days of receiving all completed paperwork.
Once your application is complete and submitted you will receive your certificate(s) within 20 days
A sample of the certificate you may receive, depending on your products and which application you completed.
Step Two: Apostille or Authenticate Your Document
Now that you have your Free Sale Certificate issued and signed by an FDA official you need an apostille or authentication for your document to be used in either your participating Hague country, an apostille, or a Non-Hague participating country, an authentication.
According to The US Department of State – Office of Authentications
“The U.S. Department of State issues both authentications and Apostilles. The determination of which certificate is issued is based on the country in which the document will be used.“
To prepare your documents for foreign use in a Non-Hague country your final steps are:
First, the U.S. Department of State. You have 3 choices:
- You’ll need an authentication or an apostille by the U.S. Department of State. If you take it there, you will have to arrive between 8 AM and 9 AM to drop off your documents. The person at the desk will look through your documents to be sure all the correct steps were followed, then give you a receipt for your papers, and an appointment time in 2 – 3 days. You will return at your appointment day during those same hours to pick up your authenticated document. The fee for this service is $8 per apostille and is payable in US Dollars by check, money order or by major credit/debit cards. The address to drop your off your documents: Office of Authentications, 600 19th Street NW, Washington, DC 20006.
- Mailing your document to the U.S. Department of State requires that you complete their form DS-4194, which lists your documents and the corresponding country(s) along with basic personal information. The total fee of $8 per certification must be paid by a money order drawn on a U.S. bank or a check made out to the U.S. Department of State. You can mail it to: Office of Authentications, CA/PPT/S/TO/AUT, 44132 Mercure Circle, PO Box 1206, Sterling, VA 20166-1206.
- A private courier can perform delivery service for you, both the drop off and the pick up, and can follow through the next step at the Embassy of the destination country. Be sure to do your research of the private companies because the fees and experience vary widely. California Apostille has many years of experience, and their fee is the lowest in the United States. You would contact the courier and make arrangements with them to have your documents, apostilled/certified at the Secretary of State, then authenticated at the U.S. Department of State, and finally legalized at the destination country’s Embassy.
Second, the destination country’s Embassy. There are 2 choices:
- All Embassies have different hours, fees and turnaround times. If you plan to visit them yourself, you should contact the Embassy to find out what their hours, fees and turnaround times are. Some can be hundreds of dollars in fees and some turnaround times can be a month or more. Some Embassies can be mailed to get your documents legalized, and some only allow your document to be delivered to them. You will need to consider this when making your plans to travel overseas.
- Private couriers can deliver and pick up your documents from the Embassies. Usually, when you visit their website, you will find an area showing the fees and turnaround times. They can take your document from any of the steps to be followed, up through the Embassy legalization…from certification to authentication and finally to legalization at the Embassy. California Apostille is a thorough private company that will perform each or all steps with experience and at a low fee. Be sure to research any private company for fees and experience.
To contact California Apostille to use their services, you can contact us by phone at (323) 977-4900, or send an email to [email protected].
The post Step By Step Guide to Apostille Your Certificate of Free Sale appeared first on California Apostille.
