‘Blue-box’ requirements
'Blue-box' requirements (May 2023) [Track version]
User Guide for the electronic…
User Guide for the electronic Application Form for a Marketing Authorisation (September 2023) [Track Version]
EMA/CMDh explanatory notes on Variation Application Form – Human medicinal products only (December 2021) [Track version]
EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only (December 2025) [Track version]
QP declaration [Track…
QP declaration [Track version] (February 2025)
Variations [Track version]
Variations [Track version] (December 2023)
Practical guidance for…
Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (January 2024) [Track version]
Leaflet on ICH
ICH is pleased to announce the publication of a Leaflet on ICH.
Updated EU Harmonised technical eCTD guidance now available
An updated version of the EU Harmonised technical eCTD guidance and the related release notes are now available. The updated guidance enters into force 1st February 2022.
Meeting 14-16 December…
Meeting 14-16 December 2021: Agenda - MinutesMeeting 09-11 November 2021: Agenda - MinutesMeeting 12-14 October 2021: Agenda - MinutesMeeting 14-16 September 2021: Agenda - MinutesMeeting 20-22 July 2021: Agenda - MinutesMeeting 22-23 June 2021: Agenda - Minutes - Correction 25/08/21Meeting 18-20 May 2021: Agenda - MinutesMeeting 20-22 April 2021: Agenda - MinutesMeeting 23-25 March 2021: Agenda - MinutesMeeting 23-24 February 2021: Agenda - Minute - Update 07/10/2021Meeting 26-27 January 2021: Agenda - Minutes
National recommendations for…
National recommendations for requests to act as RMS (March 2024)