Wholesale Distribution Authorisations and GDP certificates can now be transferred to EudraGMDP
We can now transfer Wholesale Distribution Authorisations (WDA) and Good Distribution Practice (GDP) certificates to EudraGMDP, a Community database in the EU.
We have updated our IT systems so that we can now transfer information about wholesale dealers to EudraGMDP. The information is transferred according to the latest versions of the EU harmonised formats for WDAs and GDP certificates.
Read more about the applicable format for WDAs in EMA's Compilation of Community Procedures on Inspections and Exchange of Information (on pages 203-206, and about the format for GDP certificates on pages 207-210).
Changes to Wholesale Distribution Authorisations in case of updates
We have made one change to the application form and the authorisation template so that they match EMA's format:
- We have removed sections 2.5 and 3.4. In future, these activities will be specified on the authorisation and transferred to EudraGMDP as comments to sections 2.5 and 3.4. The reason is that EMA only allows to transfer an activity once per site.
You find our updated application form for WDAs under
Application for wholesale distribution of medicines within the EU/EEA
Transfers in practice
In practice, the technical update means that:
- We have updated our application form for Wholesale Distribution Authorisations.
- We have updated our template for authorisation for wholesale distribution.
- We have updated our guidelines so that they reflect sections 2.5 and 3.4.
- All WDAs issued after 1 September 2012 have been transferred to EudraGMDP.
- WDAs issued before 1 September 2012 will be transferred at the next change of the authorisation. If you want a WDA to be transferred now, please write to firstname.lastname@example.org and ask for an update of your WDA. In practice, you have to apply for a change, because the valid authorisation must be transferred to EMA's format for WDAs.
- GDP certificates will be transferred to EudraGMDP as GDP inspections are carried out.
At present, we issue WDAs without 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.
EudraGMDP is a Community database in the EU administered by the European Medicines Agency (EMA). The database contains information about manufacturers and wholesale dealers 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.
Access to EudraGMDP: http://eudragmp.ema.europa.eu/