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FDA Apostille for Pakistan

FDA Certificates · Pakistan

FDA Apostille for Pakistan

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.

  • Hague membersince 9 March 2023
  • Apostilledocument route
  • Urdu & Englishofficial language
  • 9 daysstandard processing
FDA Digital Certificate Sample

Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.

Processing time 9 business days
  • No document shipping is required.
  • You may update your own FedEx AWB or create a new one.
  • Expedited processing times are offered.
  • Credit card payments are accepted.
  • The U.S. Department of State fee is already included.
  • No separate U.S. Department of State form is needed.
  • Track your order history and expenditures online.
Exp. Service fee$68 / Doc.
US Dept. of State fee$20 / Doc.
Total:$88 / Doc.
See expedited options →
FDA Certificate Sample 1 FDA Certificate Sample 2

Why Pakistan Asks for an Apostilled FDA Certificate

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.

Which FDA Certificate Does Your Pakistani Importer Need?

Match your product to the Pakistani authority that reviews it and the FDA certificate that authority normally expects.

Product typePakistani authorityFDA certificate
MedicinesDrug Regulatory Authority of Pakistan (DRAP)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesDrug Regulatory Authority of Pakistan (DRAP)Certificate to a Foreign Government (CFG), Certificate of Exportability
Nutraceuticals & health productsDRAP, which oversees health and OTC (non-drug) productsCertificate of Free Sale (CFS)
Food, ingredients & infant formulaFederal and provincial food authoritiesCertificate to a Foreign Government (CFG), Health Certificate
Cosmetics & personal careThe competent Pakistani authority, depending on the productCertificate 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.

How the FDA Apostille for Pakistan Works

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.

  1. Upload your FDA certificate

    Send the digital certificate exactly as the FDA issued it and choose Pakistan as the destination.

  2. We review it

    We check that the certificate is complete, FDA-signed and ready for the State Department.

  3. State Department apostille

    We submit it to the Office of Authentications and track it until the apostille is issued.

  4. FedEx delivery

    The apostilled certificate ships to you, your importer or your agent in Islamabad or anywhere else.

Exporting to Pakistan: What to Prepare

No more embassy attestation

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.

A licensed importer with sole agency

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 an official language

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.

Five-year registrations

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.

FDA Apostille Cost for Pakistan

ItemAmountNotes
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.

FDA Apostille for Pakistan: FAQs

Is Pakistan a member of the Hague Apostille Convention?

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.

Do I still need Pakistani embassy attestation for FDA documents?

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.

Does DRAP recognize the U.S. FDA?

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.

Does my FDA certificate need to be translated into Urdu?

Generally not. English is an official language in Pakistan, and DRAP accepts English documents.

Which FDA certificate do I need for DRAP registration?

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.

How long does an FDA apostille for Pakistan take and what does it cost?

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.

Health Certificate

Collagen and gelatin exports (EU health certificate or SRM certificate).

Nearby destinations

Get Your FDA Certificate Apostilled for Pakistan

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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FDA Digital Certificate Sample

Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.

Processing time

9 business days
  • We accept credit card payments.
  • Track your order history and expenses online.
  • The U.S. Department of State fee is already included.
  • Submit the files you received from the FDA electronically.
  • We use the State Department minimum processing time.
  • You may update your own FedEx air waybill or purchase a new one.
  • U.S. Department of State Form DS-4194 is not required; we handle it.

Exp. Service fee

US Dept. of State fee

Total:

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