Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Apostille for Spain
FDA Apostille for Spain
Spain has applied the Hague Apostille Convention since 25 September 1978. An FDA export certificate for a buyer in Madrid or Barcelona needs only a U.S. Department of State apostille. No legalization at the Spanish Embassy or a consulate is required. Upload the digital certificate and we return it apostilled by FedEx.
- Hague membersince 25 September 1978
- Apostilledocument route
- Spanishofficial language
- 9 daysstandard processing
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time 9 business days
- No document shipping is required.
- You may update your own FedEx AWB or create a new one.
- Expedited processing times are offered.
- Credit card payments are accepted.
- The U.S. Department of State fee is already included.
- No separate U.S. Department of State form is needed.
- Track your order history and expenditures online.
Exp. Service fee$68 / Doc.
US Dept. of State fee$20 / Doc.
Total:$88 / Doc.
Why Spain Asks for an Apostilled FDA Certificate
Spain applies EU product law. Medicines need an EU or Spanish marketing authorization, medical devices need CE marking, and cosmetics and food supplements are notified before sale. The FDA certificate doesn't stand in for any of these. Spanish importers, hospital purchasing departments and regulatory consultants still ask for an apostilled one, because it shows the product is legally made and sold in the United States.
Spain is also a common base for companies that sell into Latin America, where FDA certificates are often central to sanitary registration. Whichever market the certificate is for, only the U.S. Department of State can apostille it, because the FDA is a federal agency. We take care of the request and ship the apostilled certificate to you or straight to your Spanish partner.
Which FDA Certificate Does Your Spanish Importer Need?
Match your product to the Spanish authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Spanish authority | FDA certificate |
|---|---|---|
| Medicines | AEMPS (Spanish Agency of Medicines and Medical Devices) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | AEMPS, under the EU Medical Device Regulation | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | AESAN (Spanish Agency for Food Safety and Nutrition) and regional health authorities | Certificate to a Foreign Government (CFG), Health Certificate |
| Food supplements & medical foods | Regional health authorities, with registration through AESAN | Certificate of Free Sale (CFS) |
| Cosmetics | AEMPS, under the EU Cosmetics Regulation | Certificate for Cosmetics |
AEMPS and AESAN apply EU rules in Spain, and Spain's autonomous communities handle part of the food and supplement oversight. Your apostilled FDA certificate supports buyer, tender and regulatory files. It doesn't replace CE marking, EU marketing authorization or EU notifications.
How the FDA Apostille for Spain Works
The Hague Apostille Convention has been in force for Spain since 25 September 1978, so a single apostille from the U.S. Department of State makes your FDA certificate valid there. There is no embassy visit, consular stamp or second legalization step.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Spain as the destination.
We review it
We check that the certificate is complete, FDA-signed and ready for the State Department.
State Department apostille
We submit it to the Office of Authentications and track it until the apostille is issued.
FedEx delivery
The apostilled certificate ships to you, your importer or your agent in Madrid or anywhere else.
Exporting to Spain: What to Prepare
Sworn translation when asked
Spanish authorities work in Spanish. Many buyers accept the English FDA certificate, but official files may ask for a translation by a sworn translator (traductor jurado). If so, translate after the apostille is attached so the apostille is included.
Regional structure
Spain's 17 autonomous communities run their own health services and handle part of the food and supplement oversight. Hospital tenders are usually issued by a regional health service, so expect requirements to differ slightly from one region to another. Check each tender's document list.
Canary Islands, Ceuta and Melilla
The Canary Islands and the cities of Ceuta and Melilla are part of Spain, so FDA certificates for buyers there take the same apostille. Customs and tax rules differ from mainland Spain, so confirm the import paperwork with your local partner.
A launch pad for Latin America
Many Spanish distributors also handle registrations in Mexico, Colombia, Peru and other Spanish-speaking markets. Most of these accept apostilles, but each authority usually wants its own original. Order one apostille for each country on your plan.
FDA Apostille Cost for Spain
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $68 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $88/ doc. | Standard processing: 9 business days. Expedited options available. |
FDA Apostille for Spain: FAQs
Is Spain a member of the Hague Apostille Convention?
Yes. Spain ratified the Convention, and it has applied there since 25 September 1978. A U.S. Department of State apostille is enough, so no Spanish embassy or consulate legalization is required.
Does my FDA certificate need a sworn Spanish translation?
Sometimes. Many buyers accept English, but official files or tenders may ask for a translation by a traductor jurado. Have it done after the apostille is attached.
Who regulates medicines, devices and cosmetics in Spain?
AEMPS, the Spanish Agency of Medicines and Medical Devices, which applies EU rules. Food is overseen by AESAN together with the regional health authorities, which also handle food supplement notifications.
Does the apostille work for the Canary Islands, Ceuta and Melilla?
Yes. They are part of Spain, so the same U.S. Department of State apostille applies. Customs and tax rules differ, so confirm the import paperwork with your partner.
Can an apostilled FDA certificate replace EU requirements in Spain?
No. It proves your product's U.S. regulatory status. Selling in Spain still requires EU compliance, such as a marketing authorization, CE marking or EU notification, depending on the product.
How long does an FDA apostille for Spain take and what does it cost?
Standard processing takes 9 business days and costs $88per document: our $68 service fee plus the $20 U.S. Department of State fee. Expedited options are available.
FDA Certificates We Apostille for Spain
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Apostilled for Spain
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
9 business days
- We accept credit card payments.
- Track your order history and expenses online.
- The U.S. Department of State fee is already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee
US Dept. of State fee
Total:
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