Notification-based authorisation of Asian medicines with no indication:
Electronic recording of notifications using the HOMANT Asia software
Art. 31 of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Authorisation of Complementary and Phytotherapeutic Products (KPTPO; SR 812.212.24) specifies a notification-based authorisation for Asian medicines with no indication (notification procedure).
The preconditions to be satisfied for the application of the notification procedure and additional requirements are summarised and explained in the guidance document Authorisation of Asian medicinal products HMV4.
Art. 41 KPTPO requires single notifications to be submitted in the form defined by the Agency. Swissmedic provides a corresponding electronic form and has developed the HOMANT Asia software for this purpose. HOMANT Asia and any updates are available on the Swissmedic website for download free of charge. Instructions for installing and using the software are described in the manuel Handbuch HOMANT Asia HMV4.
The list of documented traditional Asian substances (TAS list, Annex 10 KPTPO) and the list of standard works (Annex 9 KPTPO), version dated 01.07.2021, form the master data currently included in HOMANT Asia. Any updates to the master data are likewise available on the Swissmedic website.
PC with Microsoft Windows XP, Windows 7 or Windows 10 (including installation of .net Framework)
The installation of .net Framework and therefore the installation of HOMANT Asia are not supported by the IOS operating system (Apple).
Download the installer (the set-up program) HOMANT Asia-1.0.10.exe from the Swissmedic website, then run the program locally on your computer and follow the instructions on the screen. Administrator rights on the computer concerned are needed to install the software.