Oxcarbazepine Date of publication: 18/10/2023

The ICH Secretariat is pleased to announce the publication of Q9(R1) Quality Risk Management Training Materials.

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Human submissions (option to choose Article 18 as submission type).

The guideline on eSubmissions for Veterinary products version 3.1 has now been published. It will enter into force on 1 November 2023 (see links under section Current Guidance).

The electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with a comprehensive update on the progress of the web-based Human variations eAF implementation on Product Lifecycle Management (PLM) Portal.

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. [...]

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