Since 1 June 2023, applicants must provide in the application forms for any type of submission (new dossiers, sister files, revisions and renewals) the EMA SPOR/OMS ORG_ID and LOC_ID (unique identifiers for an organisation and its locations) for all companies involved in Certification of suitability (CEP) dossiers.
The ORG_ID and LOC_ID are mentioned on CEPs in addition to companies’ names and addresses. For ongoing submissions, for which a CEP is to be issued, applicants are requested to provide the data during the evaluation of the dossier before any CEP can be issued.
ORG_ID and LOC_ID identifiers are assigned and managed by the European Medicines Agency (EMA), using the SPOR/OMS database. More information on the SPOR/OMS database and how to register your organisation in the database is available on the EMA website. Any questions related to obtaining the necessary SPOR/OMS identifiers should be addressed to the EMA.
Companies that do not yet have an ORG_ID and LOC_ID must therefore register as soon as possible. It is the CEP holder’s responsibility to ensure that this information is also available for intermediate manufacturers, to invite them to register as needed and provide consistently the same SPOR ORG_ID and LOC_ID and address.
Companies which already have an ORG_ID and LOC_ID should ensure that their name and addresses given both to the EDQM and in the SPOR/OMS database are aligned. It should be noted that the EDQM will use the entries in the SPOR/OMS database as a reference in order to have more consistency in the data.