Swissmedic launches own GMDP Database

The Swiss health authority Swissmedic is bringing a SwissGMDP database into operation, similar to the European Medicine Agency's (EMA) EudraGMDP database. It will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The certificates in the SwissGMDP database will include all authorised activities, i.e. unlike EudraGMDP, the GDP activities and Switzerland-specific GMP activities of Swiss companies will also be listed in the certificates. All companies, authorities and individuals can easily view a company's GMP/GDP status using the SwissGMDP database.

Furthermore, SwissGMDP enables a query of all establishment licence holders with a valid establishment license including their sites and licenced operations and will replace the previous table of establishment licence holders.

The SwissGMDP database:

• is accessible to the general public,
• enables free access to all electronic GMP/GDP certificates,
• also includes Switzerland-specific activities,
• enables access to GDP certificates of companies that only have GDP activities in their licence,
• improves the exchange of information between regulatory authorities and the public, including the pharma industry,
• helps to protect the medicinal product distribution chain and the active substance supply chain by making it easier to check legitimate players.

Thanks to the SwissGMDP database, the vast majority of companies will be able to greatly reduce their expenses for issuing GMP/GDP certificates, as all GMP/GDP certificates will be available free of charge. To maintain the SwissGMDP database, only a fee will be charged for each request or inspection-driven update of the GMP/GDP relevant data.

The SwissGMDP is expected to be launched on the Swissmedic website in the last first quarter of 2024, with the exact date to be announced in the coming months.

Source: Swissmedic