Back CEP 2.0: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications

EDQM Strasbourg, France 20/03/2023
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CEP 2.0: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications

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:

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”.