Update to the Forms: New Authorisation of Human Medicinal Products and Variations and Authorisation Extensions HAM

5. Juli 2024 – Swissmedic has updated the authorisation forms for human medicinal products to clarify how to describe product indications and to simplify consents for information sharing with partner authorities. The changes include detailed guidelines on specifying the disease, target population, therapy line, prior therapies, and combination use in applications. Simplified consents for information sharing have been introduced, and outdated sections related to COVID-19 regulations have been removed. The revised forms are effective from 1 July 2024.

For more information, see here.