Added in January 22 January …
Added in January 22 January NEW - 23-25 January 2024 CMDh agenda
Meeting 23-25 January: Agenda…
Meeting 23-25 January: Agenda
This is the ‘Recently Published’…
This is the 'Recently Published' page for the Human Medicines section
Member: Vacant National Institute…
Member: Vacant National Institute of Pharmacy and Nutrition Zrínyi U. 3 H-1051 BUDAPEST
Updated eAF v1.26.0.0 Human MAA and v1.26.0.1 Vet MAA now available
Updated v1.26.0.0 Human MAA eAF is now available on the eAF website. The form is ready for immediate use. The change implemented in this version is a minor bug fix (related to Annex 5.19).
Survey for eSubmission website open until Monday, 18 December 2023
In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the eSubmission website.
Survey for PSUR Repository open until Monday, 18 December 2023
In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the PSUR Repository.
New submission unit to be used for requesting a Re-examination of an CHMP Opinion
An updated version of the eSubmission Gateway XML delivery file user interface will be available starting with 1 December 2023, 18:00 CET. This update introduces in the delivery file for Human submissions the option to choose "Re-examination" submission unit for various submission types. Use this unit for requesting re-examination of opinion for MAA, extension, Type [...]
Added in December 11 December …
Added in December 11 December NEW - 12-14 December 2023 CMDh agenda