To make a long story short, SPOR (Substance, Product, Organization and Referential) is the European Medicines Agency’s (EMA’s) requirement to implement the standards on data for medicines, the so-called ISO IDMP1 standards (IDentification of Medicinal Products), in the European Union. The purpose of IDMP standards is to allow for the exchange of medicinal product information in a consistent and robust manner.
In order to comply with the ISO IDMP standards, as mandated by Commission Implementing Regulation (EU) No. 520/2012 (articles 25 and 26), the EMA is delivering four SPOR data management services for the centralized management of master data:
Substance Management Services (SMS): Harmonized data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.
Product Management Services (PMS): Harmonized data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorization, packaging and medicinal information).
Organization Management Services (OMS): Data comprising the organization name and location address, for organizations such as marketing authorization holders, sponsors, regulatory authorities and manufacturers.
Referential Management Services (RMS): List of terms (controlled vocabularies) to describe attributes of products, e.g., lists of dosage forms, units of measurement and routes of administration.
After an extension of the original deadline, pharmaceutical companies are invited to start to replace their current data submission format in the Article 57 Database from the eXtended EudraVigilance Product Report Message (XEVPRM2) format to the new ISO IDMP compatible format (HL7 FHIR3).