SPOR: substances, products, organisations and referentials
SPOR is EMA's set of four master data services (substances, products, organisations, referentials) that implement ISO IDMP for EU regulatory submissions.
SPOR is the operational form of the ISO IDMP standards in the EU. Article 57(2) of Regulation (EC) No 726/2004 obliges marketing authorisation holders to submit electronic information on their authorised medicines to EMA, and Article 25 of Commission Implementing Regulation (EU) No 520/2012 requires the use of the internationally agreed formats and terminologies of ISO 11615, 11616, 11238, 11239 and 11240. EMA built four services to hold that data: the Substance Management Service (SMS), the Product Management Service (PMS), the Organisation Management Service (OMS) and the Referentials Management Service (RMS).
Each service is a controlled vocabulary with its own identifiers. RMS holds lists such as pharmaceutical forms, routes of administration, units and country codes. OMS holds organisations and their locations. SMS holds substance names and identifiers, and PMS holds product data drawn from the authorisation. The services went live for OMS and RMS in 2017; PMS is being populated through the PLM Portal and the migration of Article 57 data, and SMS is replacing the substance lists that the xEVMPD used. Regulators use the same identifiers, so an organisation or a term entered once can be reused in an electronic application form, in IRIS and in the PLM Portal without retyping.
In practice SPOR shows up when a regulatory team fills in a form. Where an eAF or an IRIS request asks for an organisation, it expects an OMS ORG-ID and LOC-ID, not free text; where it asks for a pharmaceutical form or a unit, it expects an RMS term. If the needed value does not exist, the company must raise a change request in the relevant service and wait for EMA to validate it before the form can be completed.
What goes wrong: teams discover a missing OMS entry for a new contract manufacturer the day before a submission; the same site is registered twice under slightly different address formats, so later submissions point at the wrong LOC-ID; a locally used pharmaceutical form name is not an RMS term and has to be mapped; and product data in PMS disagrees with the approved SmPC because nobody owns the reconciliation. Master data management, with a named owner and a check before each submission, is the usual fix.
Used in
Teams that maintain SPOR data keep each product's registrations and identifiers in one record in Atlas, so what is submitted matches what is authorised.
Related terms
- OMS: organisation management serviceThe Organisation Management Service (OMS) is EMA's master list of organisations and locations whose identifiers must be used in EU regulatory forms.
- xEVMPD: extended EudraVigilance medicinal product dictionary (Article 57 database)The xEVMPD, or Article 57 database, is EMA's record of every medicine authorised in the EU, which holders must keep updated within 15 days of changes.
- PLM Portal: EMA product lifecycle management portalThe PLM Portal is EMA's product lifecycle management platform for electronic application forms and eSubmissions for centrally authorised products.
- eAF: electronic application formThe electronic application form (eAF) is the mandatory EU form for marketing authorisation, variation and renewal applications in every procedure type.
- IRIS: EMA portal for regulatory and scientific proceduresIRIS is EMA's online platform for orphan designation, scientific advice, paediatric, parallel distribution and other procedures outside the dossier.
Last updated