Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Embassy Legalization for Sierra Leone
FDA Embassy Legalization for Sierra Leone
Sierra Leone is not a party to the Hague Apostille Convention, so FDA certificates for the Pharmacy Board of Sierra Leone must be legalized. We have your certificate authenticated by the U.S. Department of State and legalized by the Embassy of Sierra Leone in Washington, then FedEx it to you or your local agent in Freetown in about 15 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Englishofficial language
- 15 daysstandard processing
Send Your FDA Certificate for Processing
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 15 business days
- We accept credit card payments.
- Track your order history and expenses online.
- U.S. Department of State and embassy fees are 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$120 / Doc.
US Dept. of State fee$20 / Doc.
Embassy of Sierra Leone fee$100 / Doc.
Total:$240 / Doc.
FedEx return shipping is available for completed documents.
See expedited options →Why Sierra Leone Asks for a Legalized FDA Certificate
Medicines, medical devices and in-vitro diagnostics in Sierra Leone are registered by the Pharmacy Board of Sierra Leone (PBSL). Foreign manufacturers must appoint a local agent, either a registered pharmaceutical importation company or an accredited manufacturer's representative registered as a pharmacist in Sierra Leone. A device or IVD application includes a free sale certificate, a certificate of analysis, manufacturing licences, a sterility certificate where relevant, and samples.
PBSL also offers a fast track. Under its guideline in effect since 17 February 2021, products already approved by a stringent regulatory authority, defined by ICH membership, or prequalified by WHO can receive a decision within 21 calendar days. The United States is an ICH founding member, so FDA-approved medicines are well placed for that route, and a legalized FDA certificate supports the evidence of approval.
Which FDA Certificate Does Your Sierra Leonean Importer Need?
Match your product to the Sierra Leonean authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Sierra Leonean authority | FDA certificate |
|---|---|---|
| Medicines | Pharmacy Board of Sierra Leone (PBSL) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & IVDs | PBSL | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Sierra Leonean health and standards authorities, depending on the product | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | PBSL or food authorities, depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | PBSL; confirm the current route with your agent | Certificate for Cosmetics |
PBSL registers medicines, devices and diagnostics, while food falls under other authorities. Your Sierra Leonean agent will confirm which authority reviews your product and which FDA certificate it needs.
How FDA Embassy Legalization for Sierra Leone Works
Sierra Leone is not a party to the Hague Apostille Convention, so it does not accept apostilles. Your FDA certificate is first authenticated by the U.S. Department of State and then legalized by the Embassy of Sierra Leone.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Sierra Leone as the destination.
State Department authentication
We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.
Embassy legalization
We take the authenticated certificate to the Embassy of Sierra Leone for legalization, which takes about 6 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Freetown or anywhere else.
Exporting to Sierra Leone: What to Prepare
A 21-day fast track
PBSL's fast-track guideline gives products approved by stringent regulators or prequalified by WHO a decision within 21 calendar days. Your dossier should match the original approval, with a few Sierra Leone-specific additions such as Zone IVB stability data where applicable.
Devices in about three months
Device and IVD registrations are typically completed within about three months of a complete dossier and samples. Certificates have been issued for one year and are renewable, so plan regular updates.
A licensed local agent
Your local agent must be a registered pharmaceutical importation company or an accredited manufacturer's representative who is a pharmacist registered in Sierra Leone. Make sure the agent's details match across all documents.
English-language files
English is Sierra Leone's official language, so English FDA certificates can usually be filed without translation once they are legalized.
FDA Embassy Legalization Cost for Sierra Leone
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $120 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | State Department authentication, about 9 business days |
| Embassy of Sierra Leone fee | $100 / doc. | Embassy legalization, about 6 business days. Paid by us on your behalf |
| Total | $240 / doc. | Standard processing: 15 business days. Expedited options available. |
FDA Embassy Legalization for Sierra Leone: FAQs
Does Sierra Leone accept apostilles?
No. Sierra Leone is not a party to the Hague Apostille Convention, so FDA certificates need U.S. Department of State authentication followed by legalization at the Embassy of Sierra Leone.
How long does FDA embassy legalization for Sierra Leone take?
About 15 business days: roughly 9 at the State Department and 6 at the Embassy of Sierra Leone, followed by FedEx delivery.
How much does it cost?
$240 per document, covering our $120 service fee, the $20 State Department fee and the $100 Embassy of Sierra Leone fee.
Who regulates medicines in Sierra Leone?
The Pharmacy Board of Sierra Leone (PBSL), which registers medicines, medical devices and in-vitro diagnostics.
Is there a fast track for FDA-approved products?
Yes. PBSL's fast-track guideline covers products approved by stringent regulatory authorities or prequalified by WHO, with a decision within 21 calendar days.
Which FDA certificate does Sierra Leone need?
PBSL files typically use a CPP for medicines, a CFG for devices and foods, a Certificate of Free Sale for supplements and a Certificate for Cosmetics for cosmetic products. Products not sold in the U.S. need a Certificate of Exportability.
FDA Certificates We Legalize for Sierra Leone
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Legalized for Sierra Leone
Upload your FDA certificate today and receive it legalized by FedEx in 15 business days, for $240 per document with State Department and embassy fees included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
15 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
Embassy of Sierra Leone fee
Total:
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