Export certificates for medicinal products

An export certificate is a declaration from the Danish Medicines Agency based on a manufacturer’s licence for a Danish company, a marketing authorisation granted for a specific medicinal product or a requested inspection. An export certificate is completed by the company itself, and the Danish Medicines Agency then authorises the certificate. The export certificate is used to certify the medicinal product or manufacturer when exporting medicinal products.

Application via digital form

We prefer applications to be submitted using the digital form.

When applying via the digital form, we always receive the requested information and we can process the application faster. See instructions below.

The form shall state the contact details and the type of export certificate to be requested. Up to 10 items can be attached with a total limit of 50 MB. 

It is recommended to use PC when filling out the form. Supports Edge, Chrome and Firefox.

Certificate types

Export certificates are drawn up in accordance with the WHO certification scheme. You can read more about export certificates on the WHO website under the Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce.

The Danish Medicines Agency authorises the following types of export certificates on request.

1. Certificate of Pharmaceutical Product (CPP1/CPP2)
2. Statement of Licensing of Pharmaceutical Product (LSPP)
3. Statement on Good Manufacturing Practices (CGMP)
4. Statement on Good Distribution Practices (CGDP)
5. Batch Certificate of a Pharmaceutical Product (BCPP)
6. TSE certificates
7. Credibility statements

Please note that we issue an EU GMP certificate to pharmaceutical manufacturers after any completed GMP inspection if the inspected company operates under EU GMP rules. These GMP certificates are issued in a common EU format, published by EMA, see EMA’s website under Community procedures. We will phase out the issuance of CGMP (No 3) as these EU GMP certificates become widely used and recognised in those countries that require proof of GMP compliance. You can read more about GMP certificates on our website under Issuance of GMP certificates.

Instructions

The company itself completes the export certificate using the templates below and submits the export certificate via an export certificate form. The company completes the certificates according to guidelines in the guide.

• Issue of export certificates for medicinal products
• Explanatory notes for CPP 1 and 2

For further guidance, see WHO Q & A to complete CPPs: WHO Questions and answers (Q & A)

We prefer the completed export certificate to be sent via export certificate form. If there are challenges with the form, the completed export certificate can instead be submitted by email. Please notify any urgent cases on tel. + 45 4488 9595.

The Danish Medicines Agency prints the required certificates on certificate paper with digital certification, and seals the certificate with our oblate.

For companies where production and release takes place exclusively abroad, a certificate must be applied for in the country concerned.

BCPP and credibility statements can be sent electronically on the company’s own letterhead. If there is a special need for certification on the company’s original letterhead, please contact us on + 45 4488 9595 for agreement on the process before sending the documents.

Templates

Here you will find templates for completing export certificates.

• CPP-1 en
• CPP-1 es
• CPP-2
• LSPP
• CGMP third country
• CGMP-API-NV
• CGMP-API-V
• CGMP-NP
• CGMP-PP
• CGMP-PP-es
• CGDP

If you have any questions about export certificates, please contact us by Send an email or call us on + 45 44 88 95 95.