The European Medicines Agency (EMA) has released a new version of the Gateway (v3.4.0.0) where they have introduced some minor, but significant additions and/or changes.
EMA highly advises to use the new version of the application to provide more complete .xml data set, especially in regards to Brexit related procedure part:
- 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.
If you have any question with regards to the EMA Gateway, please contact us at eCTD@asphalion.com
