Calyx RIM Administration

SPOR Maintenance

The SPOR Maintenance section in Calyx RIM Data Administration is designed to maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service.

To facilitate the reliable exchange of Medicinal Product information the European Medicines Agency (EMA) introduces Substance, Product, Organisation, and Referential (SPOR) program.

According to the roadmap designed by EMA the SPOR support starts with an introduction of OMS and RMS components:
  • OMS - Organisartions management service. OMS manages organisation master data, comprising organisation name and location address, for organisations such as marketing authorisation holders (MAH), sponsors, regulatory authorities and manufacturers.
  • RMS - Referentials management service. RMS manages the referential master data. In Calyx RIM it is included to the Data Administration > SPOR Maintenance section as lists of values used to describe the attributes of a medicinal product. For example: dosage forms, units of measure, and routes of administration (ROA).

You can add and modify values, and set the status of a value to active or inactive from Data Administration.

When you select a value under SPOR Maintenance, a page opens with a table of all values that have been defined. You can sort these values by column, define the number of values to be displayed on the page, or export the table data to Excel.

You should have Data Administration set to Yes in the Security Administration > Home Page Access section to be able to access the SPOR Maintenance values.