Export certificates for medicinal products

Updated 22 March 2017

An export certificate is a declaration from the Danish Medicines Agency 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 Medicines Agency 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 the 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

We issue an EU GMP certificate to pharmaceutical manufacturers 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’s 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 export certificate electronically by using the templates below. You must fill in the certificates in accordance with the guidelines.

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

Please send the filled in export certificate electronically (Word file) 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, please call us on + 45 4488 9779.

The Danish Medicines Agency prints the requested certificates on our certificate paper with digital certification and stamp the certificate with our seal.

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

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.

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.

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