- Related sequence number for most types of Human submissions can be entered. This allows for easy cross-referencing of related submissions.
- Users can indicate if a Risk Management Plan is included (MAA, Variation Type IB and II, Extension, PAM, Renewal).
- The name of any CAPs for which the same changes are being applied outside of the procedure can be provided (Variations Type IB and II).
- New checkbox to indicate whether the change is a Brexit related procedure (Variations Type IA, IAIN, IB and II, MA Transfer, Notification 61-3 (Human products only)).
- A submission can be referenced by selecting a procedure number from a predefined list for clinical data publication-FV and -RP.
- Multiple procedure numbers can be added from a predefined list to reference the submission (applicable for all post-authorisation CAP submissions when the submission unit is closing.
- A length of renewal can be specified for all initial renewal submissions.
- For ASMF submissions, a procedure number can be selected from a predefined list to reference the submission
- A new validation for Veterinary VneeS submissions now includes VNeeS (pharmaceutical product) v.2.5 and VNeeS (immunological product) v.2.5.
As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.