Authorisation without indication by means of notification (notification procedure)
Asian medicinal products without indication can be authorised by means of notification (notification procedure) in accordance with the requirements stipulated in Art. 31 KPTPO[1].
In keeping with the notification procedure, extensive documentation of preclinical and clinical aspects, in particular, does not need to be submitted. Instead, these aspects are reviewed on the basis of the required reference to the list of documented traditional Asian substances (TAS list, Annex 10 KPTPO) and the list of standard works (Annex 9 KPTPO) in conjunction with the requirements and restrictions that have been defined.
[1] Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Complementary and Phytotherapeutic Products (SR 812.212.24)
The notification procedure comprises several process steps which are completed and approved in a sequential authorisation procedure:
Primary characteristics of an Asian medicinal product without indication approved using the notification procedure:
Exclusively substances on the TAS list (Annex 10 KPTPO) and exclusively classic formulations according to a standard work in the list of standard works (Annex 9 KPTPO)
Substances and preparations manufactured from them, compositions and dosage forms are derived from the approach of the corresponding Asian treatment
The treatments are provided individually and their safety and efficacy are ensured by specialists trained in the Asian treatment in question
Information for patients according to Annex 5.4 TPLRO[2]
The medicinal product is identified in the Information for patients and on the packs as a “Chinese medicinal product” or an “Ayurvedic medicinal product” or a “Tibetan medicinal product”
The name of the medicinal product may contain only the designation shown in Annex 1b TPLRO
[2]Ordinance of the Swiss Agency for Therapeutic Products on the Licensing Requirements for Therapeutic Products (SR 812.212.22)
