The PMS and SMS build on the data foundations of the Referentials Management Service (RMS) and Organisation Management Service (OMS), which EMA launched in June 2017.
The SPOR services support the implementation of ISO IDMP standards in the EU / EEA. The PMS and SMS will manage two of the four domains of substance, product, organisation and referentials (SPOR) master data in pharmaceutical regulatory processes. SPOR data management services will facilitate the reliable exchange of medicinal product information in a robust and consistent manner. The European Medicines Agency (EMA) is delivering a Product Management Service (PMS) and a Substance Management Service (SMS) to support regulatory activities in the European Union (EU).
This content applies to human medicines only.
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