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FDA Apostille for Russia

FDA Certificates · Russia

FDA Apostille for Russia

Russia has applied the Hague Apostille Convention since 31 May 1992. An FDA export certificate for a Russian registration file needs one U.S. Department of State apostille. You don't need Russian consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.

  • Hague membersince 31 May 1992
  • Apostilledocument route
  • Russianofficial 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 Russia Asks for an Apostilled FDA Certificate

Russia registers medicines and medical devices within the framework of the Eurasian Economic Union (EAEU), which it shares with Armenia, Belarus, Kazakhstan and Kyrgyzstan. Food supplements, cosmetics and many food products follow common EAEU technical regulations. Registration files built under these rules usually include proof that the product is legally marketed in its country of origin, and for U.S. products that proof comes from the FDA.

Russian authorities generally expect foreign official documents to be apostilled and translated into Russian. The FDA is a federal agency, so its certificates can only be apostilled by the U.S. Department of State. We handle that request and ship the apostilled certificate to you or to your authorized representative.

Which FDA Certificate Does Your Russian Importer Need?

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

Product typeRussian authorityFDA certificate
MedicinesMinistry of Health of the Russian Federation, under EAEU registration rulesCertificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesRoszdravnadzor (Federal Service for Surveillance in Healthcare), under EAEU rulesCertificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaRospotrebnadzor, under EAEU technical regulationsCertificate to a Foreign Government (CFG), Health Certificate
Dietary supplements & medical foodsRospotrebnadzor (state registration under EAEU rules)Certificate of Free Sale (CFS)
Cosmetics & personal careEAEU technical regulation on perfumery and cosmetic productsCertificate for Cosmetics

Russian and EAEU requirements change regularly, and some national procedures are being replaced by EAEU-wide ones. Your authorized representative in Russia will confirm the current route and the FDA certificate it needs.

How the FDA Apostille for Russia Works

The Hague Apostille Convention has been in force for Russia since 31 May 1992, 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 Russia 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 Moscow or anywhere else.

Exporting to Russia: What to Prepare

Check sanctions and export controls first

U.S. sanctions and export controls apply to trade with Russia. U.S. authorities have issued authorizations covering many food, medicine and medical device transactions, but restrictions remain on certain parties, items and payments. Confirm your shipment is compliant before you invest in registration paperwork.

Notarized Russian translation

Russian authorities work in Russian and usually ask for foreign documents to be translated, with the translator's signature notarized in Russia. Have the FDA certificate apostilled first, then translated, so the apostille is part of the certified translation.

One registration, several markets

EAEU registrations for medicines and devices can be used across the Union's member states. If your file targets Russia and Kazakhstan, Armenia or Kyrgyzstan too, confirm whether one set of apostilled documents will serve the whole procedure, or whether each country needs its own.

An authorized representative

Foreign manufacturers work through an authorized representative registered in the EAEU, who files and holds the registration. Make sure the manufacturer and product names on your FDA certificate match the representative's application exactly.

FDA Apostille Cost for Russia

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 Russia: FAQs

Is Russia a member of the Hague Apostille Convention?

Yes. The Convention has applied in Russia since 31 May 1992, following the succession from the former USSR. A U.S. Department of State apostille is enough, so no Russian consulate legalization is required.

Can I still export FDA-regulated products to Russia?

It depends on the product, the parties involved and how payment is made. U.S. sanctions and export controls apply, although many food, medicine and medical device transactions are covered by authorizations. Check compliance with your trade counsel before shipping. Our service covers only the apostille of your FDA certificate.

Does my FDA certificate need a Russian translation?

Usually yes. Russian authorities generally require a Russian translation of foreign documents, often with the translator's signature notarized. Translate after the apostille is attached.

What is the EAEU and how does it affect registration?

The Eurasian Economic Union includes Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. It sets common registration rules for medicines and devices and shared technical regulations for food, supplements and cosmetics, so one registration can cover several member states.

Which FDA certificate do I need for Russia?

A CPP for medicines, a CFG for medical devices and conventional foods, a Certificate of Free Sale for dietary supplements, and a Certificate for Cosmetics for cosmetic products. Products not sold in the U.S. need a Certificate of Exportability.

How long does an FDA apostille for Russia 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 Russia

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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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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