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Certificate of Pharmaceutical Product (COPP) Legalization for Arab Countries
Arab drug regulators, such as Saudi Arabia’s SFDA, Egypt’s drug authority and the UAE’s health authorities, generally require a legalized Certificate of a Pharmaceutical Product (COPP) before they register a U.S. medicine. The COPP follows the WHO certification format and is issued by the FDA, so it is legalized as a federal document. The Arab American Chamber of Commerce handles the U.S. Department of State and embassy steps.
Issued by the FDA, legalized in Washington. A COPP never needs a notary or a Secretary of State. It goes straight to the U.S. Department of State. For Saudi Arabia, Morocco, Bahrain and Algeria that apostille is enough. Drug registrations in the other Arab countries also need the embassy.
What a COPP Is
A Certificate of a Pharmaceutical Product (also called a CPP) is issued under the WHO certification scheme for pharmaceuticals moving in international trade. The FDA issues it to confirm a drug’s U.S. marketing status and that the manufacturing site follows good manufacturing practice (GMP). Importing countries use it as the cornerstone of the drug registration file.
Approved drug COPP
For drugs approved and marketed in the U.S.
Most commonExport-only COPP
For drugs made for export that aren’t marketed in the U.S. Some regulators accept it less readily.
Check acceptanceOne COPP per product
Each drug, strength and dosage form usually needs its own certificate.
Per productNot for devices or food
Those use the FDA Certificate to Foreign Government (CFG).
See CFGChoose the Destination Country
Choose the country where the drug will be registered to start your order.
Country
U.S. steps
Final step
U.S. stepsOriginal → U.S. Department of State apostille
Final stepApostille (since July 9, 2026)
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEgyptian Embassy or consulate
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Oman (business documents since 2021)
U.S. stepsOriginal → U.S. Department of State authentication
Final stepPalestinian legalization arranged by our team
U.S. stepsOriginal → U.S. Department of State apostille
Final stepApostille (since December 2022)
U.S. stepsOriginal → U.S. Department of State
Final stepUAE Embassy (through VFS Global), then MOFA in the UAE
Embassy fees for pharmaceutical certificates vary by country. We confirm the amount with your order.
How a COPP Is Legalized
- Apply to the FDA for each productRequest a COPP naming the importing country, with the product name, strength, dosage form and manufacturing site exactly as in your registration dossier.
- Review the certificateCheck the product details, marketing status and GMP statement. Any mismatch with the dossier is a common reason for rejection.
- Office of AuthenticationsWe take the original COPP to the U.S. Department of State. For Saudi Arabia, Morocco, Bahrain and Algeria, the apostille issued there is the final certificate.
- Embassy legalizationFor embassy countries, the embassy in Washington legalizes the authenticated COPP. For the UAE, it goes through VFS Global, then MOFA.
- Into the dossierReturned with tracking, ready for your regulatory agent to submit.
Common mistakes: notarizing the COPP, sending it to a state office, combining several products where the regulator wants one COPP per product, or a manufacturing site that differs from the dossier. Plan around the regulator’s submission deadline.
Required Documents
What to send us
- The original COPP from the FDA, one per product, exactly as issued.
- Product details from your dossier, so we can compare them.
- Your online order for the destination country, paid online or through Pay Invoice.
- Courier for the return: send a prepaid air waybill or USPS Priority Mail envelope, or buy the label during checkout.
Usually filed with the COPP
- GMP certificate or inspection evidence
- Certificate of analysis for the registration batch
- Letter of authorization for the marketing authorization holder or agent
- Product labeling and leaflets
The Rest of the Drug Dossier
Certificate to Foreign Government (CFG)
The FDA certificate for devices, food and cosmetics.
Federal routeProcessing Time and Fees
Apostille countries
| Saudi Arabia, Morocco, Bahrain, Algeria | U.S. Department of State apostille |
| Notary or Secretary of State | Not needed |
| Embassy step | None |
Embassy countries
| U.S. Department of State | Authentication |
| Embassy fee | By country |
| Time | Call us; plan for deadlines |
The timeline begins when the original COPPs reach our office. Checkout shows our service fee and courier cost. There is no notary or state fee.
Why Choose the Arab American Chamber of Commerce?
Federal route, every timeWe never send a COPP to a notary or state office.
Dossier matchWe compare each COPP with your product details before submission.
Deadline planningWe schedule the embassy steps around your registration deadline.
Where to Send Your COPP
Maryland office (fastest)
Arab Chamber of Commerce
1615 Bay Head Rd., Annapolis, MD 21409
(410) 349-1212
Washington, D.C. headquarters
1330 New Hampshire Ave. NW, B1, Washington, DC
(202) 347-5800
Monday to Friday, 8:00 am to 6:00 pm ET
COPP Legalization: Common Questions
Does a COPP need to be notarized?
No. It is an FDA document, so it goes straight to the U.S. Department of State for an apostille or authentication.
What is the difference between a COPP and a CFG?
A COPP is for human drugs and follows the WHO format. A CFG is the FDA’s export certificate for food, cosmetics and medical devices.
Which Arab countries accept an apostille on it?
Drug regulators in Saudi Arabia, Morocco, Bahrain and Algeria (Algeria since July 2026) accept a COPP with the State Department apostille. In Egypt, the UAE, Jordan, Kuwait, Qatar, Oman and the other Arab countries, the COPP also needs embassy legalization.
Do I need one COPP per product?
Usually yes. Each product, strength and dosage form normally has its own certificate, and each one is legalized separately.
Is a COPP for an export-only drug accepted?
Some Arab regulators accept it, and others want proof of U.S. marketing. Check with your regulatory agent before applying.
Registering a medicine in an Arab country?
Tell us the products and the regulator. We’ll plan the COPP legalization around your deadline.
Case 1 Examples
Business documents
Federally Issued documents
Case 2 Examples
Commercial Document:
Case 3 Examples
Personal Document:
Mailing
If you are using FedEx or UPS, please include a self-addressed air waybill for the return of your document.
Alternatively, you may use a USPS Priority Mail envelope with prepaid postage and a tracking number.
If you do not have a FedEx or UPS account, you can purchase an air waybill through this site in the next step.
Arab American Chamber of Commerce Headquarter Office
1330 New Hampshire Ave. NW, B1Washington, D.C. 20036
(202) 347-5800
1 888-939-ARAB
Arab Chamber of Commerce
1615 Bay Head Rd.Annapolis MD, 21409
(410) 349 - 1212
