×

Export certificates for medicinal products

Updated 25 March 2015

An export certificate is a declaration from the Danish Health and Medicines Authority based on a manufacturing authorisation for a Danish company, an issued marketing authorisation for a specific medicinal product or a requested inspection. The company fills in an export certificate form, and the Danish Health and Medicines Authority then issues the certificate. The export certificate is used to certify the medicinal product or the manufacturer when exporting medicinal products.

Export certificates are issued in accordance with the WHO certification scheme. Read more about export certificates on WHO’s website under Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce

We issue 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

In addition to export certificates, we issue an EU GMP certificate after each completed GMP inspection if the inspected company operates according to the EU GMP guidelines. GMP certificates are issued using a community format published by the EMA, see the Community procedures on the EMA website. We will phase out the issuance of CGMP (no. 3) as the EU GMP certificates become more widely used and recognised in the countries requiring documentation for GMP compliance. Read more about GMP certificates under Issuance of GMP certificates

Guidelines

You fill in the certificate form electronically and send the Word document to certificates@dkma.dk together with a cover letter (including a statement of the correctness of the information provided) and appendices, if any. In case of urgent requests that you would like us to assess on the same day, please call us on + 45 44 88 97 79 before 2 pm.

We will print the requested certificates on our certificate paper and stamp the certificate with our seal. The certification in relation to the ”traditional” stamps takes place electronically.

If your manufacturing and release activities solely take place abroad, you must apply for a certificate in the country concerned.

You find the export certificate templates under Templates. You must fill in the certificate forms in accordance with the guidelines.

For more information, see WHO's questions and answers on how to fill in a CPP: WHO Questions and answers (Q & A)

You can send BCPP and credibility statements electronically on your company's own stationery or by ordinary post if you want the certificate to be printed on your company's original stationery.

For a transition period, you can order printed certificate forms from us in accordance with the previous procedure. Please send the filled in certificate to us by ordinary post with a cover letter (including a statement of the correctness of the information provided), a copy of the certificate material for our records and a reply-paid envelope

Templates

Use the below templates to fill in an export certificate form:

If you have any questions about export certificates, please write to us at certificates@dkma.dk or call us on + 45 44 88 97 79.