Herbal medicinal products are medicinal products with specified indications, exclusively containing as active substances one or more herbal substances or one or more herbal preparations and which are not classified as complementary medicines (Art. 4 para. 1 let. aquinquies TPA, SR 812.21).
Herbal substances are whole, fragmented or cut plants, plant parts, algae, fungi or lichen in unprocessed form or in dried or fresh form and their exudates that have not been subjected to a specific treatment (Art. 4 para. 2 let. a KPTPO, SR 812.212.24).
Herbal preparations are obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. They include, for example, comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates of herbal substances (Art. 4 para. 2 let. b KPTPO).
The following are not considered to be herbal medicinal products:
- Medicinal products with pure substances isolated from plants as the active substance, for example atropine or digoxin;
- Medicinal products with synthetic or partially synthetic active substances, even if these are synthesised from raw plant-based materials, for example codeine, troxerutin or menthol;
- Medicinal products containing, in addition to herbal active substances, vitamins or minerals as active substances.
Herbal medicinal products must be of high quality, safe and effective (Art. 1 TPA) in order to be authorised by Swissmedic and permitted to be on the market.
Simplified authorisation procedures that take into account the specific characteristics of this treatment are available for herbal medicinal products.
The following diagram shows the different authorisation procedures available for herbal medicinal products: