Simplified authorisation without indication

Asian medicinal products without indication can be authorised in a simplified procedure in accordance with the requirements stipulated in Art. 30 KPTPO[1].

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.
  • For fixed combinations of medicinal products it must additionally be demonstrated that the composition is a classic formulation and that this has been used for at least ten years in at least one country in the EU or EFTA as a medicine in the respective Asian therapy.
  • 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 requirements to be met by quality documentation are the same as for the authorisation of Asian medicinal products with indication. Reference must also be made to evidence of customary uses and maximum dosages to permit safety and harmlessness to be evaluated according to the current state of science and technology.

[1] Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Complementary and Phytotherapeutic Products (SR 812.212.24)

Primary characteristics of an Asian medicinal product without indication:

  • Substances and preparations manufactured from them, compositions and dosage forms are derived from the approach of the corresponding Asian treatment
  • The treatments are provided individually and their safety and efficacy are ensured by specialists trained in the Asian treatment in question
  • Information for patients according to Annex 5.4 TPLRO[2]
  • The medicinal product is identified in the Information for patients and on the packs as a “Chinese medicinal product” or an “Ayurvedic medicinal product” or a “Tibetan medicinal product”
  • The name of the medicinal product may contain only the designation shown in Annex 1b TPLRO

[2] Ordinance of the Swiss Agency for Therapeutic Products on the Licensing Requirements for Therapeutic Products (SR 812.212.22)

Last modification 29.06.2022

Top of page