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FDA Apostille for Venezuela

FDA Certificates · Venezuela

FDA Apostille for Venezuela

Venezuela has applied the Hague Apostille Convention since 16 March 1999. An FDA export certificate for a sanitary registration in Caracas needs one U.S. Department of State apostille, with no Venezuelan consulate legalization, which is especially useful because consular services between the two countries have been limited. Upload the digital certificate and we return it apostilled by FedEx.

  • Hague membersince 16 March 1999
  • Apostilledocument route
  • Spanishofficial 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 Venezuela Asks for an Apostilled FDA Certificate

Health products in Venezuela are regulated by the Ministry of People's Power for Health (MPPS). Its Autonomous Health Comptroller Service (SACS) handles sanitary control, and the Rafael Rangel National Institute of Hygiene (INHRR) carries out technical evaluation and quality analysis, particularly for medicines. Registration files for imported products usually include a free sale certificate from the country of origin, apostilled and officially translated into Spanish.

For U.S. products, that certificate comes from the FDA. The FDA is a federal agency, so its certificates can only be apostilled by the U.S. Department of State. Because Venezuela is a Hague member, no Venezuelan consulate needs to be involved. We handle the apostille and ship the certificate to you or straight to your Venezuelan importer.

Which FDA Certificate Does Your Venezuelan Importer Need?

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

Product typeVenezuelan authorityFDA certificate
MedicinesMPPS, with technical evaluation by the INHRR (Instituto Nacional de Higiene Rafael Rangel)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesMPPS, Autonomous Health Comptroller Service (SACS)Certificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaMPPS, SACS, with INHRR analysisCertificate to a Foreign Government (CFG), Health Certificate
Dietary supplements & medical foodsMPPS, depending on how the product is classifiedCertificate of Free Sale (CFS)
Cosmetics & personal careMPPS, SACS, with INHRR analysisCertificate for Cosmetics

Venezuelan procedures and the division of work between MPPS, SACS and the INHRR change over time. Your Venezuelan importer or regulatory agent will confirm the current requirements and the FDA certificate they expect.

How the FDA Apostille for Venezuela Works

The Hague Apostille Convention has been in force for Venezuela since 16 March 1999, 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 Venezuela 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 Caracas or anywhere else.

Exporting to Venezuela: What to Prepare

Check sanctions and export controls first

U.S. sanctions apply to dealings with the Venezuelan government and certain parties. U.S. authorities have issued authorizations covering many exports of food, medicine and medical devices, but restrictions remain. Confirm your transaction is compliant before you invest in registration paperwork.

Apostille before translation

Venezuelan files require official Spanish translations, typically by a public interpreter (intérprete público). Apostille the FDA certificate first, then translate it, so the apostille is covered by the official translation.

A local importer and technical lead

Registrations are filed by a company established in Venezuela, with a representation agreement from the manufacturer and a designated technical director. Make sure the manufacturer and product names on your FDA certificate match those documents.

Five-year registrations

Sanitary registrations are generally valid for about five years. Renewals ask for updated quality and technical documents, so keep a current apostilled FDA certificate ready well before expiry.

FDA Apostille Cost for Venezuela

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 Venezuela: FAQs

Is Venezuela a member of the Hague Apostille Convention?

Yes. Venezuela joined by accession, and the Convention has applied there since 16 March 1999. A U.S. Department of State apostille is enough, so no Venezuelan consulate legalization is required.

Can I still export FDA-regulated products to Venezuela?

Often yes, but U.S. sanctions apply to certain parties and transactions. Authorizations cover many food, medicine and medical device exports. Check compliance with your trade counsel before shipping. Our service covers only the apostille of your FDA certificate.

Who regulates health products in Venezuela?

The Ministry of People's Power for Health (MPPS), through its Autonomous Health Comptroller Service (SACS), with technical evaluation by the Rafael Rangel National Institute of Hygiene (INHRR).

Does my FDA certificate need a Spanish translation?

Yes. Venezuelan registration files require official Spanish translations, usually by a public interpreter. Translate after the apostille is attached.

Which FDA certificate do I need for Venezuela?

A CPP for medicines, a CFG or Certificate of Free Sale for medical devices, a Certificate of Free Sale for supplements, and a Certificate for Cosmetics for cosmetic products. Confirm the exact certificate with your Venezuelan importer.

How long does an FDA apostille for Venezuela 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 Venezuela

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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