The ICH Secretariat is pleased to announce the publication of Q9(R1) Quality Risk Management Training Materials.
The marketing authorisation holder (MAH) is responsible to keep its product information updated in line with current scientific knowledge or recommendations. The MAH is responsible for regularly monitoring relevant sources of new information and recommendations On this website you will find links where to find recommendations and outcome resulting in amendment of the product information. [...]
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 188.8.131.52 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 (v184.108.40.206) 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 220.127.116.11 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 v18.104.22.168 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 [...]
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.