OMS: organisation management service

OMS is one of the four SPOR data management services EMA runs under Article 57(2) of Regulation (EC) No 726/2004 and Commission Implementing Regulation (EU) No 520/2012, which requires ISO IDMP formats and terminologies. It holds a single record for every organisation involved in a regulatory procedure, including marketing authorisation holders, applicants, manufacturers, testing sites and sponsors, with each physical address held as a location. An organisation carries an ORG-ID and each of its addresses a LOC-ID, and those identifiers are what the electronic application form, the PLM Portal and IRIS read.

Use of OMS data is mandatory in the eAF for human medicines in the centralised procedure and in the national, mutual recognition and decentralised procedures, and IRIS requires an OMS organisation to create a company account. The data is public and shared with national competent authorities, so a holder's legal name and registered address in OMS should match the company register, the marketing authorisation and the product information. Anyone can search the service, and a registered user can submit a change request to add an organisation or location, correct an address, or record a merger or name change. EMA validates the request against supporting documents and either accepts it or asks for more evidence.

The service matters most at the moments when a company changes: a transfer of the marketing authorisation, a legal entity rename, a new contract manufacturer or a move of the registered office. Each of those needs the OMS record updated before the related variation or transfer can be filed with the right identifiers.

What goes wrong: a submission is held up because the new manufacturing site has no LOC-ID yet and the change request is still in EMA's queue; the same site exists twice because two affiliates registered it with different address formats, and later filings point at different records; a holder renames itself in the company register but not in OMS, so forms carry the old name; and an outsourced submission partner picks a sister company's ORG-ID by mistake. Checking OMS data as part of submission readiness, and raising change requests weeks rather than days ahead, avoids most of this.