Swissmedic´s New Website for Herbal Medicinal Products

Herbal medicines are very popular and widely used in Switzerland. These medicinal products can be authorized using a simplified procedure and the Swissmedic (Swiss Agency for Therapeutic Products) ensures that the fundamental requirements for authorization are fulfilled. The website for authorization of herbal medicinal products has been completely revised and updated. The content is available in German, French, Italian and English.

Herbal Medicinal Products (HMPs)

According to Swissmedic, HMPs are medicinal products with specified indications, exclusively containing as active substances one or more herbal substances or one or more herbal preparations (e.g. extracts, essential oils, expressed juices, processed exudates, powders for encapsulation). Not considered to be HMPs are the following medicinal products (MPs):

• MPs with pure active substances isolated from plants (e.g. CBD, THC);
• MPs with synthetic or partially synthetic active substances, even if these are synthesized from raw plant-based materials (e.g. Codeine);
• MPs containing, in addition to herbal active substances, vitamins or minerals as active substances.

HMPs must be in general of high quality, safe and effective in order to be authorized by Swissmedic and permitted to be on the market. However, several simplified authorization procedures are available for HMPs. In addition to "well-established" and "traditional" use, there is also the option provided for "HMPs with known active substance", which means a medicinal product with an active substance that is contained in another MP that is or was authorized by Swissmedic (for detailed information please see this table). The dossier must include a complete documentation of quality, toxicology and pharmacology, and clinical aspects. The applicant must demonstrate pharmaceutical / therapeutic equivalence to the Swiss comparator.

Round Table

The Swissmedic and the herbal medicines industry and associations meet regularly to discuss topics relating to the regulation of HMPs at a Round Table. According to Swissmedic, the "Round Table enables the various stakeholders to make their concerns heard in order to respond promptly and appropriately to regulatory and technical changes and signals".

More information is available at Swissmedic´s New Website on Complementary and Herbal Medicines (CHM).