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All Danish Wholesale Distribution Authorisations now appear from EudraGMDP

16 September 2016

All Danish Wholesale Distribution Authorisations have been updated to the applicable European format and entered into the common EU database, EudraGMDP, which is available to the general public.

EudraGMDP is a common European database operated by the European Medicines Agency (EMA). The database contains information about manufacturers and wholesale distributors in the EU/EEA, both authorisations and certificates. Moreover, the database contains information about non-compliance as well as companies registered as API manufacturers, distributors or importers.

The EudraGMDP database is available to the general public.

The applicable format for a Wholesale Distribution Authorisation is displayed in the EMA’s Compilation of Community Procedures on Inspections and Exchange of Information (pages 203-206).

Upload of GDP Certificates

GDP Certificates are also uploaded to EudraGMDP. However, it is not yet possible to search for GDP Certificates for all Danish wholesale distributors, because GDP Certificates will be uploaded to EudraGMDP as GDP inspections are carried out. At present, we issue Wholesale Distribution Authorisations without an expiry date, whereas GDP Certificates are valid for a maximum of five years from the most recent date of inspection. A shorter period of validity may be specified in the certificate.