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
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 [...]