Updated 19 April 2012
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 Danish Health and Medicines Authority issues export certificates on request.
Certificates can be issued for:
- companies' general manufacturing of medicinal products (Statement on Good Manufacturering Practices). Read more about the phasing out of WHO CGMP certificates on this page: Issuance of GMP certificates.
- a specific medicinal product (Certificate of a Pharmaceutical Product) (Danish companies only)
- marketing authorisation (Statement on Licensing Status)
as well as few other kinds.
For further information, please see the "Guidelines for issuing export certificates for medicinal products" in the box.
It is the company that fills in the certificate form in accordance with the guidelines.
The certificate form can be ordered from the Danish Health and Medicines Authority and should be duly completed and returned with:
- a cover letter, including a statement about the correctness of the information provided
- a copy of the certificate material for the Danish Health and Medicines Authority's records
- a reply-paid envelope.
For companies whose manufacturing and release activities solely take place abroad, a certificate must be applied for in the country concerned.