Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
FDA Apostille for Denmark
Denmark has applied the Hague Apostille Convention since 29 December 2006. A U.S. Department of State apostille is all your FDA export certificate needs to be accepted in Copenhagen, with no Danish embassy legalization. Upload the digital certificate and we return it apostilled by FedEx.
- Hague membersince 29 December 2006
- Apostilledocument route
- Danishofficial language
- 9 daysstandard processing
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.
Why Denmark Asks for an Apostilled FDA Certificate
Denmark is an EU member, so products reach its market under EU rules: a marketing authorization for medicines, CE marking for medical devices, and EU notification for cosmetics and food supplements. An FDA certificate doesn't replace any of these. Danish distributors, hospital and pharmacy tenders, and EU registration agents still often ask for one as proof that your product is legally made and sold in the United States.
Danish companies that buy U.S. ingredients, devices or finished products to supply other markets often need apostilled FDA certificates for their own customers abroad. Either way, the FDA is a federal agency, so only the U.S. Department of State can apostille its certificates. We handle that step and ship the result to you or straight to your Danish partner.
Which FDA Certificate Does Your Danish Importer Need?
Match your product to the Danish authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Danish authority | FDA certificate |
|---|---|---|
| Medicines | Danish Medicines Agency (Lægemiddelstyrelsen) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | Danish Medicines Agency (Lægemiddelstyrelsen), under the EU Medical Device Regulation | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | Danish Veterinary and Food Administration (Fødevarestyrelsen) | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & medical foods | Danish Veterinary and Food Administration (Fødevarestyrelsen) | Certificate of Free Sale (CFS) |
| Cosmetics | Danish Environmental Protection Agency (Miljøstyrelsen), under the EU Cosmetics Regulation | Certificate for Cosmetics |
These authorities enforce EU rules in Denmark. The FDA certificate supports your file but doesn't replace EU requirements such as CE marking or cosmetic product notification. Your Danish distributor or EU representative will confirm what each buyer or authority expects.
How the FDA Apostille for Denmark Works
The Hague Apostille Convention has been in force for Denmark since 29 December 2006, 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.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Denmark as the destination.
We review it
We check that the certificate is complete, FDA-signed and ready for the State Department.
State Department apostille
We submit it to the Office of Authentications and track it until the apostille is issued.
FedEx delivery
The apostilled certificate ships to you, your importer or your agent in Copenhagen or anywhere else.
Exporting to Denmark: What to Prepare
EU rules come first
In Denmark, an apostilled FDA certificate is supporting evidence. Medicines still need an EU or Danish marketing authorization, devices need CE marking, and cosmetics need an EU Responsible Person and notification. Plan these separately. The apostille confirms your U.S. status, not EU compliance.
Tenders and distributor files
Danish regions buy medicines and medical supplies through public tenders, and distributors build supplier files for each product line. Both often ask for apostilled FDA certificates. Check whether the tender wants an original or a certified copy, and order one apostille for each original you will submit.
English is often accepted
Danish is the official language, but Danish authorities and companies commonly work with English-language documents. FDA certificates are issued in English, so a translation is often unnecessary. Confirm this with your buyer before ordering one.
Faroe Islands and Greenland
When Denmark joined the Convention it excluded the Faroe Islands and Greenland. The Convention was extended to the Faroe Islands in 2021. If your certificate is going to Greenland, contact us before ordering so we can confirm the right route.
FDA Apostille Cost for Denmark
| 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. |
FDA Apostille for Denmark: FAQs
Is Denmark a member of the Hague Apostille Convention?
Yes. The Convention has applied in Denmark since 29 December 2006, so an apostille from the U.S. Department of State is enough. No Danish embassy or consulate legalization is required.
Do I need to translate my FDA certificate into Danish?
Usually not. Danish authorities and businesses commonly accept English documents, and FDA certificates are issued in English. Ask your Danish buyer or authority to confirm before you pay for a translation.
Does an apostilled FDA certificate let me sell my product in Denmark?
No. It proves your product's U.S. regulatory status. Selling in Denmark still requires EU compliance, such as a marketing authorization for medicines, CE marking for devices, or EU notification for cosmetics. The certificate supports those files and distributor or tender requirements.
Which FDA certificate do Danish buyers usually ask for?
A CPP for medicines, a CFG for medical devices and conventional foods, a Certificate of Free Sale for dietary supplements, and a Certificate for Cosmetics for cosmetic products. Products made only for export need a Certificate of Exportability.
Is the apostille valid for the Faroe Islands and Greenland?
The Convention has applied to the Faroe Islands since Denmark extended it in 2021. Greenland was excluded when Denmark joined, so contact us before ordering a certificate for use there.
How long does an FDA apostille for Denmark 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 if your tender or shipment deadline is close.
FDA Certificates We Apostille for Denmark
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Apostilled for Denmark
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee included.
Start Your Order Ask a Question
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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