Simplified authorisation with indication
Homeopathic and anthroposophic medicinal products with indication can be authorised in a simplified procedure in accordance with the requirements of Art. 24 of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Complementary and Phytotherapeutic Products (KPTPO).
In addition to quality and safety, harmlessness and the curative effect according to the treatment principle in question must be documented adequately and plausibly. The scope of the documentation is determined by the requirements stipulated in Annex 2 KPTPO.
Fundamental requirements must additionally be fulfilled:
- The starting materials and preparations manufactured from them must comply with the defined requirements and manufacturing specifications and be customary and sufficiently well-known in the treatment in question.
- Reference may also be made to the list of homeopathic and anthroposophic substances (HAS list, Annex 6 KPTPO) and the list of Schüssler salts (SC list, Annex 7 KPTPO) to provide additional evidence.
- The indications and dosage forms must be customary and sufficiently well-known in the treatment in question.
The wording of the indication for homeopathic and anthroposophic medicinal products must be aligned with the treatment in question (e.g. “According to homeopathic principles, for use ...”) and may not imply any therapeutic effects which go beyond the informative value of the bibliographic data submitted. The indications for medicinal products in dispensing category D are limited to supportive treatment in the context of self-medication with professional advice. In justified cases, the Information for healthcare professionals can be dispensed with for these medicinal products.
Supplementary information
