A medicinal product can only be authorised for an alternative treatment not specifically mentioned in the KPTPO if the treatment is deemed to be part of complementary medicine and has additionally been known to the respective experts for many years and is established.
Whether or not the treatment in question fulfils this condition can be determined in a Scientific Advice Meeting or Presubmission Meeting before the authorisation application is submitted. The applicant must provide the corresponding evidence.
The requirements of Art. 35 KPTPO apply to the simplified authorisation of a medicinal product for another alternative treatment.
If the issue has not already been clarified in a Scientific Advice Meeting or a Presubmission Meeting, evidence that the treatment is part of complementary medicine and has been known to the respective experts for many years and is established must be provided at the latest with the application for authorisation of a medicinal product.
The application must furthermore contain documentation of the quality and safety, the composition and the indication in accordance with the requirements of Art. 35 KPTPO. It must be demonstrated that the active substances, the combinability of active substances, the dosage form and the indications have been used and known for many years in the corresponding treatment. Corresponding evidence may be provided in the form of professional publications (reference books, publications in specialist journals) provided that the specialist literature published in an official Swiss language or in English contains sufficient evidence and the findings can be transferred to the medicinal product in question.
Other possible authorisation procedures, taking into account the requirements of each: