MHRA establishes own GMDP Database

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

EudraGMDP is a GMP and GDP related database of the European Community containing manufacturing and wholesale authorisations, GMP certificates and non-Compliance Reports published in the EudraGMDP database. These reports are generated by the competent authorities, which conduct GMP inspections at the premises and upload their reports into the database. In 2019, Swissmedic has begun to enter information on GMP inspections and manufacturing authorisations for Swiss manufacturers into the database.

But it seems UK is looking for a different approach. Now, after Brexit, the U.K. MHRA has established an MHRA-GMDP database as "Alpha Release" (new service) containing information issued by the MHRA relating to manufacturing, wholesale authorisations and certificates and non-compliance statements. The MHRA GMDP database has been backloaded with data from EudraGMDP (data prior to 01 January 2021).