Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Embassy Legalization for Mozambique
FDA Embassy Legalization for Mozambique
Mozambique is not a party to the Hague Apostille Convention, so FDA certificates for its medicines regulator, ANARME, must be legalized. We have your certificate authenticated by the U.S. Department of State and legalized by the Embassy of Mozambique in Washington, then FedEx it to you or your importer in Maputo in about 16 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Portugueseofficial language
- 16 daysstandard processing
Prepare Your FDA Documents for Mozambique
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 16 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 Mozambique fee$180 / Doc.
Total:$320 / Doc.
FedEx return shipping is available for completed documents.
See expedited options →Why Mozambique Asks for a Legalized FDA Certificate
Medicines and vaccines in Mozambique are regulated by the Autoridade Nacional Reguladora de Medicamentos (ANARME), a semi-autonomous national agency. In August 2026, the World Health Organization recognized ANARME at maturity level 3 for regulating medicines and imported vaccines, describing it as a stable, well-functioning and integrated regulatory system. Mozambique became the tenth African country, and the first Portuguese-speaking one, to reach that level.
A stronger regulator means more thorough reviews. Earlier studies of ANARME's registration process pointed to limited reliance on other regulators' decisions and bottlenecks in processing marketing authorizations, and the agency committed to revising its guidelines and meeting applicants more often. For U.S. exporters, complete files with clear proof of FDA approval, legalized by the Embassy of Mozambique, are the best way to move smoothly through the system.
Which FDA Certificate Does Your Mozambican Importer Need?
Match your product to the Mozambican authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Mozambican authority | FDA certificate |
|---|---|---|
| Medicines & vaccines | Autoridade Nacional Reguladora de Medicamentos (ANARME) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | ANARME | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Mozambican health and trade authorities, depending on the product | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | ANARME or food authorities, depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | Health authorities; confirm the current route with your importer | Certificate for Cosmetics |
ANARME regulates medicines, vaccines and other health products, while food falls under other authorities. Your Mozambican importer will confirm which authority reviews your product and which FDA certificate it needs.
How FDA Embassy Legalization for Mozambique Works
Mozambique 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 Mozambique.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Mozambique 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 Mozambique for legalization, which takes about 7 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Maputo or anywhere else.
Exporting to Mozambique: What to Prepare
A WHO maturity level 3 regulator
Since August 2026, ANARME has held WHO maturity level 3 status for medicines and imported vaccines. Expect systematic, well-documented reviews, and send complete files from the start.
Portuguese translations
Portuguese is Mozambique's official language, and authorities generally expect foreign documents in Portuguese. Have your legalized FDA certificate translated after the embassy stamp is added.
Budget for the embassy step
The Embassy of Mozambique's $180 fee is the largest part of the $320 total, and its step takes about 7 business days. Ask your importer which certificates are essential before ordering several.
A gateway to southern Africa
Mozambique's ports serve inland neighbors such as Malawi, Zambia and Zimbabwe. If your importer distributes regionally, check whether each destination needs its own legalized certificate.
FDA Embassy Legalization Cost for Mozambique
| 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 Mozambique fee | $180 / doc. | Embassy legalization, about 7 business days. Paid by us on your behalf |
| Total | $320 / doc. | Standard processing: 16 business days. Expedited options available. |
FDA Embassy Legalization for Mozambique: FAQs
Does Mozambique accept apostilles?
No. Mozambique 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 Mozambique.
How long does FDA embassy legalization for Mozambique take?
About 16 business days: roughly 9 at the State Department and 7 at the Embassy of Mozambique, followed by FedEx delivery.
How much does it cost?
$320 per document, made up of our $120 service fee, the $20 State Department fee and the $180 Embassy of Mozambique fee.
Who regulates medicines in Mozambique?
ANARME, the national medicines regulatory authority, which WHO recognized at maturity level 3 in August 2026.
Does my FDA certificate need a Portuguese translation?
Usually yes. Portuguese is the official language, so plan for a translation made after legalization.
Which FDA certificate does Mozambique need?
Mozambican 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 Mozambique
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 Mozambique
Upload your FDA certificate today and receive it legalized by FedEx in 16 business days, for $320 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
16 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 Mozambique fee
Total:
Click here toupload your first FDA digital filePDF only · or drag and drop it here