Swissmedic has updated the choice of medicinal product categories. The changes take into account the current state of scientific and technical knowledge and contribute to up-to-date classification of medicinal products.
Applicants are therefore requested to select the medicinal product category according to the updated list in the drop down menu on page 1 or 2 of the forms mentioned for relevant applications submitted from 1 November 2026.
In addition, new framework conditions for the central electronic publication of officially mandated information materials have been in force since 1 August 2026 (see Changes to the guidance document RMP ICH E2E information submission HMP).
Medicinal products with a known active substance (KAS) with or without innovation and biosimilars publish the officially mandated information material by conformation and with reference to the relevant reference medicinal product/reference product. More detailed information on this is to be provided by the applicant in sections 6.10 KAS with/without innovation and biosimilars and/or 5.10 New pharmaceutical form of the forms mentioned.
The revised forms are valid with effect from 1 November 2026.