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FDA Apostille for Portugal

FDA Certificates · Portugal

FDA Apostille for Portugal

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.

  • Hague membersince 4 February 1969
  • Apostilledocument route
  • Portugueseofficial language
  • 9 daysstandard processing
FDA Digital Certificate Sample

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.
See expedited options →
FDA Certificate Sample 1 FDA Certificate Sample 2

Why Portugal Asks for an Apostilled FDA Certificate

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.

Which FDA Certificate Does Your Portuguese Importer Need?

Match your product to the Portuguese authority that reviews it and the FDA certificate that authority normally expects.

Product typePortuguese authorityFDA certificate
MedicinesINFARMED (National Authority of Medicines and Health Products)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesINFARMED, under the EU Medical Device RegulationCertificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaDGAV (Directorate-General for Food and Veterinary Affairs)Certificate to a Foreign Government (CFG), Health Certificate
Food supplements & medical foodsDGAV, which receives food supplement notificationsCertificate of Free Sale (CFS)
CosmeticsINFARMED, under the EU Cosmetics RegulationCertificate 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.

How the FDA Apostille for Portugal Works

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.

  1. Upload your FDA certificate

    Send the digital certificate exactly as the FDA issued it and choose Portugal as the destination.

  2. We review it

    We check that the certificate is complete, FDA-signed and ready for the State Department.

  3. State Department apostille

    We submit it to the Office of Authentications and track it until the apostille is issued.

  4. FedEx delivery

    The apostilled certificate ships to you, your importer or your agent in Lisbon or anywhere else.

Exporting to Portugal: What to Prepare

Portuguese-language files

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.

Public hospital tenders

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

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.

A bridge to Lusophone markets

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.

FDA Apostille Cost for Portugal

ItemAmountNotes
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 Portugal: FAQs

Is Portugal a member of the Hague Apostille Convention?

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.

Does my FDA certificate need a Portuguese translation?

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.

Who regulates medicines, devices and cosmetics in Portugal?

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.

Is the apostille valid in the Azores and Madeira?

Yes. They are autonomous regions of Portugal, so the same U.S. Department of State apostille applies.

Can I use the same certificate for Brazil or Angola?

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.

How long does an FDA apostille for Portugal 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.

Health Certificate

Collagen and gelatin exports (EU health certificate or SRM certificate).

Nearby destinations

Get Your FDA Certificate Apostilled for Portugal

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
FDA Digital Certificate Sample

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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