EDQM: Manufacturing Sites in CEP 2.0?

With regard to "CEP 2.0", the EDQM (European Directorate for the Quality of Medicines & HealthCare) has once again provided information on the "EMA SPOR/OMS ORG_IDs" and "LOC_IDs" ("unique identifiers for an organisation" / "unique identifiers for its locations") on its website.

The document "Unique identification of manufacturing sites linked to CEP applications, using SPOR OMS and GPS coordinates" was updated and revised in March 2024 and published in revision 4 on the EDQM website in April. This clarifies that the data specified for the manufacturing sites in the CEP must match the data contained in the SPOR/OMS database.

As we have already reported, "identification numbers" have been mandatory for all companies named in the CEP dossier since 1 June 2023. Together with the names and addresses of the respective companies, these will then be listed on the CEP. For this reason, it is also important to apply for the IDs at an early stage to the EMA (European Medicines Agency), which manages and assigns the two numbers. This is done via the "SPOR/OMS database". Further information on the "SPOR/OMS database" and how to register there can be found on the EMA website.

On the EDQM website you will find further information regarding the document "Unique identification of manufacturing sites linked to CEP applications, using SPOR OMS and GPS coordinates".