New Marketing Authorisation Application Form (eAF) version 1.28.0.0 for national, mutual recognition and decentralised procedures

Applicants and marketing authorisation holders can now use the new version (1.28.0.0) of the Marketing Authorisation Application Form for national, mutual recognition and decentralised procedures. From 1 September 2026, thenew version of the Marketing Authorisation Application Form (eAF)may be used. The main purpose of this update is to align product data in the application form with the ISO Identification of Medicinal Products (IDMP) model. For veterinary medicinal products, the update also reflects changes related to theNew Veterinary Regulation 2019/6(NVR). Human medicinal productsFor human medicinal products, the new version of the eAF may be used for new marketing authorisation applications submitted to national competent authorities