FAMHP (Belgian Medicine Agency) · July 17, 2026

Updated Marketing Authorisation Application Form now available for national, mutual recognition and decentralised procedures

New version 1.28.0.0 of the Marketing Authorisation Application Form aligns product data with ISO IDMP model and reflects New Veterinary Regulation 2019/6 changes.

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Applicants and marketing authorisation holders can now also access the new version (1.28.0.0) of the Marketing Authorisation Application Form for national, mutual recognition and decentralised procedures. Thenew version of the Marketing Authorisation Application Form (eAF)is now available, allowing applicants and MAHs to familiarise themselves with the upcoming changes.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 the New Veterinary Regulation 2019/6 (NVR).

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Published by FAMHP (Belgian Medicine Agency). HealthSignal links to the original document; the summary above is extracted from the source text.