Calyx RIM for XEVMPD

Retrieving the OMS Data

Important Information

In the Calyx RIM system the uniqueness of the MAH/Development Sponsor/Organisation information is determined by the EV Code value (MAH/Development Sponsor/Organisation Values > MAH/Development Sponsor XEVMPD Information), whilst in the EMA SPOR system it is determined by the Organisation Identifier value. During the synchronisation, the matching EV Code value determines the MAH/Development Sponsor/Organisation information to be added to the Calyx RIM Data Administration table. If there are more matching EV Codes in the EMA SPOR system, then the first matching information found is synchronized. The other matching entries will be listed in the Comments field in a comma delimited manner.

It is recommended to set the enable.spor.api.oms option in the insight.var file, or the Enable SPOR API for OMS option in the insightConfig.bat file, to true only if there are no MAH/Development Sponsor/Organisation Values in the Calyx RIM system. If many MAH/Development Sponsor/Organisation Values entries exist, it is recommenced to not retrieve data from the EMA SPOR system in order to eliminate the unnecessary structural data discrepancies.

When the configurations are completed in the insightConfig.bat or insight.var files, the values from the EMA SPOR REST Server are loaded to the corresponding tables in the Calyx RIM Data Administration > Other section:
  • MAH/Development Sponsor/Organisation Values

The fields are populated according to their availability on the EMA SPOR REST Server. The MAH/Development Sponsor XEVMPD Information tab is populated for the values that are loaded from the EMA SPOR REST Server if the needed data exists in the SPOR API system. If set to Active, the loaded values from the MAH/Development Sponsor/Organisation Values table can be selected for Product Family and/or Registration (becomes available for selection only if the MAH Code, or Sponsor Code is populated).

All values loaded from the EMA SPOR REST Server will have the status Inactive in Calyx RIM.

If you manually modify any loaded value, during the next loading the values are overwritten with the values from EMA SPOR REST Server.

The first loading starts in 5 minutes after all required settings are saved. The further loadings start according to the time value defined in the Defined Interval (minutes) attribute.