As part of the implementation of the CEP 2.0, it will be mandatory as of 1 June 2023 to provide, in the application forms for new dossiers, sister files and revisions and renewals, the EMA SPOR/OMS ORG_ID and LOC_ID for all companies involved in Certification of suitability (CEP) dossiers. Revised application forms for CEP submissions will be made available shortly.
The ORG_ID and LOC_ID (unique identifiers for an organisation and its locations) will be mentioned on CEPs in addition to companies’ names and addresses. For ongoing submissions, for which a CEP is to be issued, applicants will need to provide the data during the evaluation of the dossier. Companies are therefore encouraged to obtain an ORG_ID and LOC_ID as soon as possible.
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: https://spor.ema.europa.eu/sporwi/. Any questions related to obtaining the necessary SPOR/OMS identifiers should be addressed to the EMA.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) also encourages CEP applicants and manufacturers (including manufacturers of intermediaries) to register for the webinars organised by the EMA on this topic:
- SPOR and XEVMPD Data Governance: 17 April 2023, 10:00-12:00 CET
- Service Desk for SPOR and XEVMPD: 17 April 2023, 14:00-16:00 CET
- Organisation Management Service (OMS): 18 April 2023, 14:00-16:00 CET
- EMA Account Management: 20 April 2023, 14:00-16:00 CET
Stakeholders may contact the Certification Department at any time via the EDQM HelpDesk to obtain more information. Please choose “CEP-Certificates of suitability”, then select “CEP 2.0”.