Current issue of “RMS NEWS”
- RECENT COMMITTEE NEWS
Day 0 Repeat Use Procedure. The CMDh reminds marketing authorisation holders of the possibility to include additional member states by means of a purely administrative Day 0 Repeat Use procedure, e.g. to avoid potential supply shortages (see press release). In this case, both the RMS and the new CMS must agree prior to submission that the procedure can be carried out purely administratively and that the time table will be drastically shortened.
Please submit such requests with AT as RMS to email@example.com. Information about the respective fee can be found in the currently valid regulation of fees. For more details and requirements, see the BASG website.
ASMF Worksharing. CMDh would like to remind applicants and ASMF Holders when submitting an ASMF to use the ASMF Worksharing procedure, if possible. This saves resources and facilitates a harmonised review. Details of the ASMF Worksharing Procedure are published at this link on the CMDh website.
Product Information Update - Safety Reviews. The CMDh would like to remind marketing authorisation holders that an update of the product information due to a Safety Review of the MHRA should not be submitted by means of a Type IB Variation (C.I.3), as the Safety Review was not conducted by an EU/EEA agency (see press release). If desired, such changes must be submitted via a Type II Variation (C.I.4) including supporting data. It should also be noted that any deviations from an EU harmonised wording (following a recently finalised PSUSA procedure) must be duly justified by means of a Type II Variation.
BASG dialogue: Meet the Case Manager
During this BASG meeting you will have the opportunity to meet your case managers for AT=RMS procedures and to ask questions.
Take the chance and register!
More information about the exciting program can be found on the AGES Academy website, where you can also register for the event.
Please note that the talks will be in German.
When: 12.10.2021, 13:00-17:00
Where: Online via Zoom
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)