A new Drug Safety System

18.06.2019

Swissmedic will soon switch on a new Drug Safety System. 

The Go Live Date in production will take place on the 18.06.2018. 

From the technical point of view, 

  • There will be no impact on your user ID.
  • As with the present database, the follow-up reports to initial cases reported by email should still be transmitted by email.
  • Although the new database is compatible with R3 standard, Swissmedic will currently stay with R2.1. In autumn, the further proceeding concerning the introduction of R3 will be dealt with.
  • In accordance with the E2B rules, the system will check the E2B fields consequently. The acknowledgment files will be automatically generated and sent. In case of acknowledgement with code 02, MAHs are requested to enter the needed modifications according to the E2B guidelines and submit the ICSR again.

Please find attached the link to the reference document, Regulatory and Procedural Guideline from the EMA.

Supplementary information

Last modification 25.06.2019

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