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
Updated version of the eAF v1.26.0.0 variation and renewal
An updated version 1.26.0.0 of the Variation and Renewal (both Human and Veterinary) eAF is available starting with 28 November 2023, 18:00 CET.
eCTD EU Module 1 Specification proposed changes now open for public consultation Deadline: 12 January 2024
The Human Harmonisation Group has analysed the change requests received upon opening the eCTD EU Module 1 Specification for review and is now publishing the draft documents for public consultation.