Software HOMANT for the authorisation based on a notification (notification procedure) of homeopathic and anthroposophic medicinal products without indication: Updated master data available

Updated data files according to the revised HAS and SC lists and manufacturing instructions according to current pharmacopoeia editions

01.07.2025

The Complementary and Phytotherapeutic Products Ordinance (KPTPO; SR 812.212.24) provides for homeopathic and anthroposophic medicinal products without indication a marketing authorisation based on a notification in accordance with articles 27 and 28. The single notifications must be submitted in the form prescribed by Swissmedic according to article 41 of the KPTPO. Swissmedic provides a corresponding electronic form and has developed the HOMANT software for this purpose.

As part of the periodic review of the annexes to the KPTPO, the revised annexes 6 KPTPO (HAS list) and 7 KPTPO (SC list) entered into force on 1st of July 2025. The updated master data, containing the revised lists HAS and SC, is available free of charge on the Swissmedic website as an update for the HOMANT software. The master data for manufacturing instructions are also available, which include updates in accordance with Ph.Eur. Monograph 2371 and the monographs in section H 5.4.4 of the HAB - insofar as the manufacturing instructions refer to starting materials. Link to download the updated master data and for further information: HOMANT software (swissmedic.ch)