Certificate of Exportability for Algeria

Exporting Products to Algeria That Aren’t Sold in the U.S.

Not every product a U.S. company ships to Algeria is sold at home. A medicine may be made in a strength or pack size approved only abroad, a medical device may be built to a specification for the Algerian market, or labeling may be prepared in Arabic and French with claims that differ from U.S. labeling. For these products, the FDA cannot issue a Certificate to Foreign Government or a COPP, because those certificates attest to U.S. marketing. The FDA instead issues a Certificate of Exportability.

What the certificate actually states

Under sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic Act, products that are not approved or not marketed in the U.S. can still be lawfully exported if they meet certain conditions, including meeting the importing country’s specifications and not conflicting with its laws. The Certificate of Exportability confirms that the exporter has represented that the product meets those export conditions. It does not say the product is sold in the United States, and Algerian reviewers know the difference.

What that means for an Algerian dossier

Because a Certificate of Exportability is not proof of free sale, the ANPP (for medicines and medical devices) or the importer may ask for additional evidence that the product is authorized somewhere: for example, a free sale or marketing authorization from another country where it is sold, or a fuller technical justification. Discuss the dossier with your Algerian regulatory agent before applying to the FDA. The answer can decide which certificate you request and which other country’s documents you also need.

Which FDA center issues it

Exportability certificates for medical devices come from the Center for Devices and Radiological Health (CDRH), and those for human drugs from the Center for Drug Evaluation and Research (CDER). The application describes the product and the destination, so name Algeria and match the product description to the Algerian file.

The federal apostille

The certificate carries an FDA official’s signature, so its authentication belongs to the federal government. It is presented as issued, without notarization or any state involvement, to the Office of Authentications at the U.S. Department of State, which attaches the apostille. Algeria began accepting apostilles on July 9, 2026, so that single federal certification now completes the document for Algerian use, and the former Algerian Embassy legalization no longer applies.

Practical tips

Keep the exported product’s labeling, specifications and certificate wording consistent, and keep records showing that the product meets Algerian requirements. These are part of the exporter’s obligations under U.S. export rules, and they also answer the questions an Algerian reviewer is most likely to ask.