Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Since 9 March 2023, Pakistan has been part of the Hague Apostille Convention. That ended the old routine of Pakistani embassy attestation for U.S. documents. Today your FDA export certificate needs a single U.S. Department of State apostille to be accepted in Islamabad. Upload the digital certificate and we return it apostilled by FedEx.
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Before 2023, U.S. exporters sending FDA certificates to Pakistan had to go through State Department authentication followed by attestation at a Pakistani embassy or consulate. Now that Pakistan accepts apostilles, that second step is gone, which saves weeks for anyone registering products with DRAP, the Drug Regulatory Authority of Pakistan.
DRAP registers imported medicines and medical devices. In its registration guidance it lists the USFDA among the stringent regulators it recognizes, so manufacturers approved by the FDA are exempt from a separate DRAP GMP inspection. Importers still need documents from the country of origin, and for U.S. products that means FDA certificates. Only the U.S. Department of State can apostille them, because the FDA is a federal agency. We handle that and ship them to you or your Pakistani importer.
Match your product to the Pakistani authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Pakistani authority | FDA certificate |
|---|---|---|
| Medicines | Drug Regulatory Authority of Pakistan (DRAP) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | Drug Regulatory Authority of Pakistan (DRAP) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Nutraceuticals & health products | DRAP, which oversees health and OTC (non-drug) products | Certificate of Free Sale (CFS) |
| Food, ingredients & infant formula | Federal and provincial food authorities | Certificate to a Foreign Government (CFG), Health Certificate |
| Cosmetics & personal care | The competent Pakistani authority, depending on the product | Certificate for Cosmetics |
DRAP covers medicines, devices and health products. Food falls to federal and provincial food authorities, and cosmetic rules depend on product claims and ingredients. Your Pakistani importer will confirm which body reviews your product and the certificate it expects.
The Hague Apostille Convention has been in force for Pakistan since 9 March 2023, so a single apostille from the U.S. Department of State makes your FDA certificate valid there. There is no embassy visit, consular stamp or second legalization step.
Send the digital certificate exactly as the FDA issued it and choose Pakistan as the destination.
We check that the certificate is complete, FDA-signed and ready for the State Department.
We submit it to the Office of Authentications and track it until the apostille is issued.
The apostilled certificate ships to you, your importer or your agent in Islamabad or anywhere else.
If your team still budgets for Pakistani embassy attestation, you can drop it. Since 9 March 2023, a U.S. Department of State apostille completes the legalization of your FDA certificate for Pakistan.
DRAP registrations for imported finished products are filed by a Pakistani importer holding a valid drug sale license and a sole agency agreement with the manufacturer. Make sure the manufacturer and product names on the FDA certificate match that agreement.
English is one of Pakistan's official languages, and DRAP works with English-language documents. Your FDA certificate generally doesn't need translating, which saves time compared with many other markets.
DRAP drug registration certificates are generally valid for five years. Keep your FDA certificates current so renewals and variations aren't delayed waiting for a new apostilled document.
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $68 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $88/ doc. | Standard processing: 9 business days. Expedited options available. |
Yes. Pakistan joined by accession, and the Convention has applied there since 9 March 2023. A U.S. Department of State apostille is enough, so embassy or consulate attestation is no longer required.
No. Embassy attestation was required before Pakistan joined the Hague Convention. Since March 2023, a State Department apostille replaces it for U.S. federal documents such as FDA certificates.
Yes. DRAP's registration guidance lists the USFDA among the stringent regulatory authorities it recognizes. Manufacturers approved by those authorities are exempt from a separate DRAP GMP inspection, but documents such as FDA certificates are still needed.
Generally not. English is an official language in Pakistan, and DRAP accepts English documents.
A CPP for medicines, a CFG for medical devices, and a Certificate of Free Sale for nutraceuticals and health products. Conventional foods typically use a CFG, and export-only products need a Certificate of Exportability.
Standard processing takes 9 business days and costs $88per document: our $68 service fee plus the $20 U.S. Department of State fee. Expedited options are available.
Dietary supplements, medical foods and foods for special dietary use.
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
The WHO-format certificate used to register human drugs.
Products made in the U.S. for export only.
Collagen and gelatin exports (EU health certificate or SRM certificate).
Skincare, makeup, haircare and fragrance products.
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee included.
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Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.