Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Embassy Legalization for Zambia
FDA Embassy Legalization for Zambia
Zambia is outside the Hague Apostille Convention, so an FDA certificate headed for the Zambia Medicines Regulatory Authority (ZAMRA) must be legalized. After U.S. Department of State authentication, the Embassy of the Republic of Zambia in Washington adds its stamp, and we FedEx the legalized certificate to you or your Local Technical Representative in Lusaka in about 14 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Englishofficial language
- 14 daysstandard processing
Prepare Your FDA Certificate for Zambia
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 14 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 Zambia fee$45 / Doc.
Total:$185 / Doc.
Upload a digital copy of the FDA certificate online to begin the legalization request.
See expedited options →Why Zambia Asks for a Legalized FDA Certificate
ZAMRA was set up under the Medicines and Allied Substances Act No. 3 of 2013, taking over from the former Pharmaceutical Regulatory Authority. Its remit covers medicines, medical devices, in-vitro diagnostics and cosmetics, and every imported product must be registered before it can be sold. Foreign manufacturers can't apply in their own name: a Local Technical Representative holding a ZAMRA wholesale licence files the dossier through the authority's online portal and holds the marketing authorisation, which is valid for five years.
ZAMRA is a founding member of ZAZIBONA, the SADC work-sharing initiative for joint medicine assessments, and it takes part in the WHO Collaborative Registration Procedure. A 2025 study of its 2020–2023 approvals found that products already cleared by WHO prequalification or a stringent regulator such as FDA could go through a shorter verification review. That makes a properly legalized FDA certificate one of the most useful documents in a Zambian file. In 2025 WHO also supported a peer-learning visit to Rwanda to help ZAMRA work toward WHO maturity level 3.
Which FDA Certificate Does Your Zambian Importer Need?
Match your product to the Zambian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Zambian authority | FDA certificate |
|---|---|---|
| Medicines & biologicals | Zambia Medicines Regulatory Authority (ZAMRA) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & IVDs | ZAMRA (classes A to D) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Ministry of Health food safety services and the Zambia Bureau of Standards, depending on the product | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | ZAMRA or food authorities, depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | ZAMRA (product-by-product registration) | Certificate for Cosmetics |
ZAMRA registers medicines, devices, diagnostics and cosmetics, while food is handled by health and standards authorities. Your Local Technical Representative will confirm which FDA certificate the dossier needs for your product.
How FDA Embassy Legalization for Zambia Works
Zambia 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 Zambia.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Zambia 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 Zambia for legalization, which takes about 5 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Lusaka or anywhere else.
Exporting to Zambia: What to Prepare
Your representative holds the licence
The marketing authorisation is issued in the Local Technical Representative's name, and moving to a new representative usually needs the old one's cooperation. Choose your partner carefully before the legalized certificate goes into the dossier.
Reliance can shorten review
ZAMRA's verification route for products approved by stringent regulators was much faster than full review in the 2020–2023 data. A legalized FDA certificate is what proves that approval, so order it early.
One application per variant
Cosmetic variants that differ in fragrance, colour or flavour need separate ZAMRA applications. Make sure each variant is covered by an FDA certificate whose product list matches.
Plan five-year renewals
Device and medicine authorisations run for five years, and renewals should go in well before expiry. Keep a fresh legalized FDA certificate ready so the renewal isn't held up.
FDA Embassy Legalization Cost for Zambia
| 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 Zambia fee | $45 / doc. | Embassy legalization, about 5 business days. Paid by us on your behalf |
| Total | $185 / doc. | Standard processing: 14 business days. Expedited options available. |
FDA Embassy Legalization for Zambia: FAQs
Will Zambia accept a U.S. apostille?
No. Zambia hasn't joined the Hague Apostille Convention, so FDA certificates are authenticated by the U.S. Department of State and then legalized by the Embassy of Zambia in Washington.
How many business days does Zambia take?
About 14: roughly 9 for State Department authentication and 5 at the Embassy of Zambia, followed by FedEx delivery.
What is the price for Zambia?
$185 per document, covering our $120 service fee, the $20 State Department fee and the $45 Embassy of Zambia fee.
Who registers health products in Zambia?
The Zambia Medicines Regulatory Authority (ZAMRA), created by the Medicines and Allied Substances Act of 2013, which handles medicines, medical devices, diagnostics and cosmetics.
Can a U.S. company register directly with ZAMRA?
No. A Local Technical Representative with a ZAMRA wholesale licence must submit the dossier and holds the registration certificate.
Which FDA certificate does a Zambian dossier use?
ZAMRA medicine dossiers rely on a CPP, device and food files on a CFG, supplements on a Certificate of Free Sale and cosmetics on a Certificate for Cosmetics. If the product isn't marketed in the U.S., order a Certificate of Exportability instead.
FDA Certificates We Legalize for Zambia
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 Zambia
Upload your FDA certificate today and receive it legalized by FedEx in 14 business days, for $185 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
14 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 Zambia fee
Total:
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