For herbal medicinal products in the simplified authorisation procedure stipulated in Art. 14 cbis TPA (SR 812.21) in conjunction with Art. 8 – 11 KPTPO (SR 812.212.24), the results of pharmacological, toxicological and clinical testing, including all results obtained in trials in specific population groups, may be replaced by bibliographic evidence of efficacy and safety.
Herbal medicinal products with known active substance
A medicinal product with an active substance that is contained in another medicinal product that is or was authorised by Swissmedic can be authorised in a simplified procedure.
Section 7.1.1 of Guidance document Authorisation of herbal medicinal products HMV4 describes the requirements for authorisation of herbal medicinal products with known active substance.
The authorisation application must contain complete documentation of quality, toxicology and pharmacology and clinical trials. The applicant must demonstrate pharmaceutical / therapeutic equivalence to the Swiss comparator product.
However, Guidance document Authorisation of human medicinal products with known active substance HMV4 does not apply to herbal medicinal products.
Herbal medicinal products with well established use
The herbal active substance in a herbal medicinal product with well established use must have been used medically in a medicinal product in Switzerland or the EU/EFTA for at least 10 years. Complete quality documentation must be available. Furthermore, adequate studies documenting efficacy and safety must be available in the scientific literature (see Guidance document Authorisation of herbal medicinal products HMV4, section 7.1.2).
Herbal medicinal products with traditional use
If authorisation is requested for the herbal medicinal product on the basis of traditional use, a summary of those documents showing that the herbal medicinal product or a comparable medicinal product (comparator product) has been used medically for at least 30 years, and for at least 15 years in an EU/EFTA country, should be provided (see Guidance document Authorisation of herbal medicinal products HMV4, section 7.1.3).
Other valid documents can be found at:
Last modification 24.08.2022