EDQM: Updates on CEP Dossiers

Recommendation

17/18 September 2024

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

With regard to the "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 their website.

Since 1 June 2023, these "identification numbers" have been mandatory for all companies named in the CEP dossier. Together with the names and addresses of the respective companies, these will then be listed on the CEP. This applies to the submission of new dossiers, sister files, revisions and renewals. 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.

It is also pointed out that intermediate manufacturers must also be listed by means of SPOR ORG_ID, LOC_ID and address and that the CEP holder must ensure this. Furthermore, all those who already have their identification numbers should check the details regarding the company names and addresses and ensure that the details have been entered consistently and communicated both in the "SPOR/OMS database" and to the EDQM.

On the EDQM website you will find further information regarding the "EMA SPOR/OMS ORG_ID and LOC_ID" and their details on the CEPs.