Change of practice for the Danish Medicines Agency’s inspections

The Danish Medicines Agency is now implementing the digital signing system called Penneo. As of 1 November 2022, we will be using digital signatures to sign all inspection reports.

How will this impact your inspections?
We will continue to notify you of upcoming inspections by email, indicating the name of the inspector, contact information, etc, but with no signature going forward.
The inspection report will mainly stay the same, but will contain an extra signature page.
The issuance of GDP and GMP certificates will continue to take place in EudraGMDP directly. The Danish Medicines Agency will no longer be sending a PDF version of an issued certificate to the company, but will instead notify the company by email that the issued certificates are available from http://eudragmdp.ema.europa.eu/