Medicinal products for gemmotherapy

Medicinal products for gemmotherapy with indication

In accordance with Art. 35 para. 2 KPTPO, the application for simplified authorisation of medicinal products for gemmotherapy with indication must contain the quality and safety documentation stipulated in Chapter 4 KPTPO.

The starting materials and active substances for gemmotherapy for which sufficient evidence of use in this treatment has already been submitted to Swissmedic are listed in Annex 8 KPTPO (Gemmotherapy list).

This list is definitive. If other starting materials or active substances are to be used, authorisation for a corresponding medicinal product cannot be requested until Annex 8 KPTPO has been amended accordingly. The requirements that a starting material or active substance must fulfil in order to be included in the list are described in the Guidance document Criteria Annexes 4–10 KPTPO HMV4.

When determining the indication, the principles of gemmotherapy must be observed and corresponding documentation must be submitted. This documentation must show that use of the active substance(s) is customary in the indication in gemmotherapy and that it has been known for many years. If a medicinal product contains several active substances, the contribution of each active substance and their combinability must be documented. Corresponding evidence can be provided through professional publications (reference books, publications in specialist journals).

Other possible authorisation procedures, taking into account the requirements of each:

Medicinal products without indication

Medicinal products for gemmotherapy without indication for individual therapy can be authorised in the notification procedure described in Chapter 7 KPTPO. In order to be authorised they must fulfil the requirements stipulated in Art. 27 KPTPO and be labelled in accordance with Art. 44 KPTPO.

The other steps in the notification procedure are the same as for homeopathic and anthroposophic medicinal products in the notification procedure.