Asian medicinal products with indication can be authorised in a simplified procedure in accordance with the requirements stipulated in Art. 29 KPTPO.
This procedure is referred to as simplified because the applicant can provide the necessary evidence with largely bibliographic documentation instead of having to perform their own studies.
- Reference may be made to the published professional literature, such as pharmacopoeias, reference books and articles in specialist journals covering the treatment in question, to document the traditionally derived characteristics, such as the selection of the substances and preparations manufactured from them, composition, dosage form, indications and dosage recommendations, which must correspond to the approach of the Asian treatment in question.
- The evidential value of this empirical documentation is dependent on the quality, scope and transferability of the material and the consistency of the statements that can be derived. In this context, safety, harmlessness and tolerability, in particular, must be justified and documented in accordance with the current state of science and technology.
- Reference may also be made to the list of documented traditional Asian substances (TAS list, Annex 10 KPTPO) and the list of standard works (Annex 9 KPTPO) to provide additional evidence.
The quality and safety documentation stipulated in Chapter 2 KPTPO for herbal medicinal products must be submitted for herbal starting materials. The requirements for mineral or animal starting materials are based on Art. 17 and 18 KPTPO where applicable.
 Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Complementary and Phytotherapeutic Products (SR 812.212.24)