(NEW 15/11/24) How do I submit a grouped notification or grouped transfer of holdership?

Answer:

A grouped notification/transfer of holdership is a type of notification that a CEP holder may use when several CEP dossiers are impacted by one or more identical notification(s) / transfer(s) of holdership.

To be eligible to be treated as “grouped”, the notification(s) or transfer(s) of holdership declared in each dossier must be identical and no dossier-specific assessment should be required.

An eCTD submission (new sequence) is expected for each dossier concerned. Module 1 of each dossier should contain a common cover letter and the appropriate application form. Each dossier should also include an individually updated module 3.

Although an eCTD submission is expected for each dossier concerned, these should be provided to the EDQM as a single CESP submission.

Within the CESP submission, each sequence should be placed in a folder corresponding to its CEP number for easy identification. The CESP envelope should clearly indicate that the submission is grouped and the reference dossier (as detailed on the application form) should be identified.

CEP holders are reminded that since September 2023, SPOR/OMS ID have been required for all sites reported on the certificate of suitability (including for the holder). If this information has not already been provided to the EDQM, you must include it for all the dossiers in your grouped notification.