Swissmedic to Enter GMP Information into EudraGMDP

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The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

On Feb. 21, 2019, the European Medicines Agency (EMA) announced that the Swiss Agency for Therapeutic Products (Swissmedic) has begun entering information on GMP compliance and marketing authorizations relating to Swiss manufacturers into the European Union’s EudraGMDP database as part of mutual recognition agreement (MRA) between the EU and Switzerland.  New or renewed manufacturing authorizations and related GMP-certificates will be added using new templates that will replace the current paper documents. EMA stated in a press release that the new practice will “lead to easier information-sharing and efficiency gains for all stakeholders.”

The EudraGMDP database holds manufacturing, import, and wholesale-distribution authorizations as well as GMP and good distribution practice certificates, providing compliance status online for industry stakeholders. The MRA between the EU and Switzerland was updated in August 2017 to include an amendment on data entry by Swissmedic to EudraGMDP.


Source: EMA