A new version of the joint EMA/CMDh User guide for the electronic application form for a Marketing Authorisation is available on the CMDh website.

Member: Heili Tikk Alternate: Kairi Laius State Agency of Medicines 1 Nooruse Street EE-50411 TARTU

Added in October 4 October UPDATE - CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product

Oxycodone                                End of Procedure: 24/03/2021 Date of Publication: 27/09/2023

Member: Vacant Alternate: Mathilde Geynet-Kovacs Agence nationale de sécurité du médicament et des produits de santé (ANSM) 143-147 Bvd Anatole France FR-93285 SAINT-DENIS CEDEX

New version 1.24.0.1 of all four eAFs is now available to allow the users a short transitional period before the start of the mandatory use of the form. The changes in this version of the forms (v1.24.0.1) relate to the Member State, OMS and Country fields in all 4 forms and the changes are implemented [...]

An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available. Version 1.24.0.0 of all the 4 electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 month transitional period, and mandatory use from November 2020. The release v1.24.0.0 will provide a major change into [...]

Users should be aware that due to essential maintenance work on EMA's infrastructure, most of EMA's computer applications, including most eSubmission systems will experience downtime between the hours of 18:00 on Friday, 17th July and 14:00 on Saturday, 18 July 2020. Please note that if you have submission deadline for your procedure on Friday, 17th [...]

Due to planned maintenance, the PSUR Repository (both NCA and Industry portals) will not be available on Saturday, 16 September 2023, between 9:00 and 17:00. For any further information, please contact EMA Service Desk

Essential maintenance work will be carried out to all eSubmission applications as part of EMA's computer application maintenance work this weekend. As a result, eSubmission systems will be intermittently unavailable between 10:00hrs and 13:00hrs of Saturday, 11 July 2020. If you have any questions, please contact the EMA Service Desk.