Simplified authorisation procedures

For herbal medicinal products in the simplified authorisation procedure stipulated in Art. 14 c^bis 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.

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 7.2.1 of the Guidance document Authorisation of herbal medicinal products 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 provide evidence that the herbal medicinal product is therapeutically or pharmaceutically equivalent to a medicinal product authorised in Switzerland (= reference product). For the known aspects, reference can be made to the authorised reference product, supported by bibliographical references. Any document protection should be taken into account.

However, the Guidance document Authorisation of human medicinal products with known active substance does not apply to herbal medicinal products.

The herbal active substance in a herbal medicinal product with well established use must have been used medically in the proposed indication in Switzerland or the EU/EFTA as a medicinal product 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, section 7.2.2).

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. The efficacy has been plausibly demonstrated on the basis of use and experience over many years, while the safety has been proven by adequate documentation (see Guidance document Authorisation of herbal medicinal products, section 7.2.3). In view of the traditionally derived indication, the product may not be a prescription-only medicine or require a medical diagnosis or medically supervised treatment.