Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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.
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
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.
Match your product to the Venezuelan authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Venezuelan authority | FDA certificate |
|---|---|---|
| Medicines | MPPS, with technical evaluation by the INHRR (Instituto Nacional de Higiene Rafael Rangel) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | MPPS, Autonomous Health Comptroller Service (SACS) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | MPPS, SACS, with INHRR analysis | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & medical foods | MPPS, depending on how the product is classified | Certificate of Free Sale (CFS) |
| Cosmetics & personal care | MPPS, SACS, with INHRR analysis | Certificate 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.
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.
Send the digital certificate exactly as the FDA issued it and choose Venezuela 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 Caracas or anywhere else.
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.
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.
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.
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.
| 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. 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.
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.
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).
Yes. Venezuelan registration files require official Spanish translations, usually by a public interpreter. Translate after the apostille is attached.
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.
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.