Certificate of Pharmaceutical Product for Bahrain

Registering U.S. Medicines in Bahrain with an FDA COPP

Medicines sold in Bahrain must be registered with the National Health Regulatory Authority (NHRA). For products made or approved in the United States, a core document in that registration is the Certificate of a Pharmaceutical Product (COPP), issued by the FDA’s Center for Drug Evaluation and Research in the World Health Organization format. It confirms whether the product is approved and marketed in the U.S., identifies the approval holder and the manufacturing sites, and states whether those sites are inspected for good manufacturing practice.

National and Gulf registration routes

Pharmaceutical companies can register a medicine nationally with the NHRA, and some also use the Gulf Cooperation Council’s centralized registration procedure, which covers several Gulf states. Both routes rely on a COPP from the reference country. Your regulatory team or local agent will decide the route, and the COPP should name the importing country or countries in the way that route requires. Ask before applying to the FDA, because the importing country is printed on the certificate.

What the NHRA compares

Reviewers check the COPP against the rest of the dossier: the product name, active ingredients and strengths, dosage form, pack sizes where stated, the product licence holder, and every manufacturing and packaging site. A site added or changed since the COPP was issued, or a trade name that differs from the one proposed for Bahrain, will generate questions. Renewals and variations often require an updated COPP, so plan for repeat certificates over a product’s life.

The federal apostille

Because the COPP is signed by an FDA official, its authentication is federal. The original is presented as issued to the Office of Authentications at the U.S. Department of State, which attaches the apostille. There is no notary and no Secretary of State involved, and adding a notarization can cause the certificate to be refused. Bahrain has been a party to the Apostille Convention since December 31, 2013, so the federal apostille is the only authentication the NHRA needs, with no embassy step.

Practical points

Order one original COPP for each dossier, and for each distributor or tender that will need one. Keep track of issue dates, because regulators generally prefer recent certificates. If a product is made only for export and not marketed in the U.S., the FDA issues a Certificate of Exportability instead, and the NHRA may then ask for additional evidence of approval elsewhere.