19-21 June 2023
As part of the implementation of the new "CEP 2.0", the EDQM (European Directorate for the Quality of Medicines & HealthCare) has now provided further information on its website.
On the one hand, it is pointed out that from 1 June 2023 it will be mandatory to provide the so-called "EMA SPOR/OMS ORG_ID and LOC_ID" ("unique identifiers for an organisation" / "unique identifiers for its locations") for all companies that are 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, so-called "sister files", revisions and renewals. Due to this, attention is also drawn to applying for the IDs early.
On the other hand, it is pointed out that the consultation period on the draft form called "Template Letter of Access" ended on 17 April 2023. Here CEP holders and users could provide guidance and input regarding the implementation of the "CEP 2.0". In this particular case, they were asked to comment on the replacement of the "access box" with the new "letter of access" on the CEP. The draft was available to view in the consultation space. The final form will now be published on the EDQM website in the near future.
On the EDQM website, in addition to the announcement of the "CEP 2.0", you will find the further information regarding the "EMA SPOR/OMS ORG_ID and LOC_ID" on the CEPs and the consultation of the "template letter of access".