Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Portugal has applied the Hague Apostille Convention since 4 February 1969. An FDA export certificate for a buyer in Lisbon or Porto needs a single U.S. Department of State apostille, with no Portuguese embassy or consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Portugal follows EU product rules. Medicines need a marketing authorization, devices carry CE marking, and cosmetics and food supplements must be notified before sale. An FDA certificate doesn't replace any of that. Portuguese importers, hospital buyers and regulatory consultants still ask for an apostilled one, because it gives independent proof that the product is legally made and sold in the United States.
Portugal also matters beyond its own borders. Many Portuguese distributors supply Brazil and the Portuguese-speaking countries of Africa, and they often need FDA paperwork for those markets as well. The FDA is a federal agency, so only the U.S. Department of State can apostille its certificates. We handle that step and ship the result to you or your Portuguese partner.
Match your product to the Portuguese authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Portuguese authority | FDA certificate |
|---|---|---|
| Medicines | INFARMED (National Authority of Medicines and Health Products) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | INFARMED, under the EU Medical Device Regulation | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | DGAV (Directorate-General for Food and Veterinary Affairs) | Certificate to a Foreign Government (CFG), Health Certificate |
| Food supplements & medical foods | DGAV, which receives food supplement notifications | Certificate of Free Sale (CFS) |
| Cosmetics | INFARMED, under the EU Cosmetics Regulation | Certificate for Cosmetics |
INFARMED and DGAV apply EU rules in Portugal. An apostilled FDA certificate supports distributor, tender and regulatory files, but it doesn't replace CE marking, EU marketing authorization or EU notifications. Your Portuguese partner or EU representative will confirm what each recipient needs.
The Hague Apostille Convention has been in force for Portugal since 4 February 1969, 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.
Send the digital certificate exactly as the FDA issued it and choose Portugal as the destination.
We check that the certificate is complete, FDA-signed and ready for the State Department.
We submit it to the Office of Authentications and track it until the apostille is issued.
The apostilled certificate ships to you, your importer or your agent in Lisbon or anywhere else.
Portuguese authorities work in Portuguese. Many buyers accept an English FDA certificate, but some may ask for a certified Portuguese translation. If they do, translate after the apostille is attached so it is covered too.
Portugal's national health service buys medicines and devices through public procurement, and tender files regularly ask for proof of regulatory status. Check whether originals are needed, and order one apostille for each original you will submit.
The Azores and Madeira are autonomous regions of Portugal, so certificates for buyers there follow exactly the same apostille route as mainland Portugal. No separate process is needed.
Exporters often use Portuguese partners to reach Brazil, Cape Verde and São Tomé, which accept apostilles, and Angola and Mozambique, which still require embassy legalization. Tell us every final destination so each certificate gets the right route.
| 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. |
Yes. Portugal ratified the Convention, and it has applied there since 4 February 1969. A U.S. Department of State apostille is enough, so no Portuguese embassy or consulate legalization is needed.
Sometimes. Many Portuguese buyers accept English, but authorities or tenders may ask for a certified Portuguese translation. Have it done after the apostille is attached.
INFARMED, the National Authority of Medicines and Health Products, which applies EU rules. Food and food supplements fall under DGAV, the Directorate-General for Food and Veterinary Affairs.
Yes. They are autonomous regions of Portugal, so the same U.S. Department of State apostille applies.
Brazil accepts apostilles, but each authority usually wants its own original, so order one apostille per country. Angola requires embassy legalization instead. See the dedicated pages for each country.
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.
Dietary supplements, medical foods and foods for special dietary use.
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
The WHO-format certificate used to register human drugs.
Products made in the U.S. for export only.
Collagen and gelatin exports (EU health certificate or SRM certificate).
Skincare, makeup, haircare and fragrance products.
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee included.
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Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.