Authorisation without indication by means of notification (notification procedure)
Complementary medicinal products used in homeopathic, anthroposophic or spagyric treatments, Schüssler therapy or gemmotherapy can be authorised in the notification procedure without indication if they fulfil the requirements stipulated in Article 27 and Article 28 of the Complementary and Phytotherapeutic Products Ordinance (KPTPO).
The HAS list (list of homeopathic and anthroposophic substances; Annex 6 KPTPO) lists the possible starting materials and the permitted dilutions or concentrations of active substances for medicinal products without indication used in homeopathic, anthroposophic and spagyric treatments.
The active substances permitted for medicinal products for Schüssler therapy are listed in the SC list (Annex 7 KPTPO).
The active substances permitted for medicinal products for gemmotherapy are listed in the Gemmotherapy list (Annex 8 KPTPO).
The majority of medicinal products without indication used in the above treatments are authorised on the basis of a notification. However, these medicinal products are subject to restrictions due to the legal requirements associated with the notification procedure.
Primary characteristics of a medicinal product without indication authorised using the notification procedure
The name of the medicinal product is exclusively the designation shown in Annex 1a TPLRO (e.g. Arnica montana).
Only active substances and potencies shown in the HAS list (Annex 6 KPTPO), the SC list (Annex 7 KPTPO) or the Gemmotherapy list (Annex 8 KPTPO).
The treatment is stated, e.g. homeopathic medicinal product, medicinal product for gemmotherapy.
No indication or dosage is given, no Information for patients.
Exclusively for use in treatment provided individually or dispensed by specialists trained in the treatment in question
How the procedure works
In accordance with Chapter 7 KPTPO, the notification comprises the basic company dossier, one or more master dossiers as required and the single notifications of the medicinal products. The modular structure, which substantially reduces the amount of documentation that must be submitted for each medicinal product by summarising information common to all preparations, enables a large number of medicinal products to be authorised efficiently.
Detailed information about the notification procedure and how a notification is submitted is summarised in a guidance document.
Swissmedic makes provision for single notifications to be recorded in electronic form using the HOMANT software (Art. 41 KPTPO). The free software and more information about it can be accessed using the link below
