COPP for Egypt

The COPP in an Egyptian Medicine Registration

Before a U.S. medicine can be imported and sold in Egypt, it has to be registered with the Egyptian Drug Authority (EDA). One of the core documents in that dossier is the Certificate of a Pharmaceutical Product, or COPP, issued by FDA’s Center for Drug Evaluation and Research in the format recommended by the World Health Organization. It tells the Egyptian regulator, in a standard layout, that the product is authorized in the United States, who makes it and where, and whether the manufacturing site is subject to regular inspection.

Why the WHO format matters

Regulators in many countries, Egypt included, rely on the WHO certification scheme because it lets them assess a foreign product without inspecting the U.S. plant themselves. The COPP answers set questions: is the product licensed for marketing in the exporting country, is it actually on the market there, who holds the license, and does the factory comply with good manufacturing practice. Answers that leave doubt, for example a product licensed but not marketed in the U.S., can lead the EDA to ask for further explanation, so your regulatory team should check these fields before the certificate is legalized.

Consistency with the dossier

The EDA compares the COPP with the rest of the registration file. The trade name, active ingredients and strength, dosage form, license holder and each manufacturing site listed should agree with the product information, the stability data and the labeling submitted in Egypt. Where packaging or release testing happens at a different site from manufacture, make sure each site appears as your Egyptian agent expects. Corrections after legalization mean a new certificate and a second round through Washington, so it pays to compare the draft carefully.

Tenders, renewals and variations

The COPP is not only needed for a first registration. Egyptian registrations are renewed periodically, and changes such as a new manufacturing site or license holder are filed as variations, each of which may need a current certificate. Hospital and government tenders in Egypt can also ask for a legalized COPP. Keep track of the issue dates of the certificates you have filed, since reviewers tend to prefer recent ones.

Legalizing the COPP for the EDA

As a federal document, the COPP skips the notary and state stages. The Arab American Chamber of Commerce submits it to the U.S. Department of State for authentication and then to the Embassy of Egypt for legalization, which Egypt requires in place of an apostille. We can return it to your office or send it directly to your Egyptian agent or importer. Processing times at both offices change through the year, so phone us for current timing and fees.