A reduced dossier containing the documents listed in Annex 3 KPTPO can be submitted with the application to Swissmedic for simplified authorisation of a homeopathic or anthroposophic medicinal product without indication containing active substances which, according to Annex 6 or Annex 7 KPTPO, cannot be authorised in the notification procedure.
In this case the following conditions for authorisation of a medicinal product without indication with reduced dossier in accordance with Art. 25 para. 1, Art. 26 para. 2 and Annex 3 KPTPO must be met in full:
a.)
In accordance with Annex 1a para. 1 let. j, no reference is made to the indication.
b.)
The proposed name of the medicinal product is exclusively a designation shown in Annex 1a para. 1 let. a KPTPO.
c.)
The medicinal product is intended exclusively for individual therapy with the following fixed text as shown in Annex 1a para. 1 let. h: “For individual therapy, use and dosage as directed by the advising professional”.
d.)
In accordance with Annex 1a para. 1 let. j, no dosage recommendation is given.
e.)
The excipients in the preparations are monographed in the pharmacopoeia, the HAB or the Ph. F. or have been approved by Swissmedic on the basis of company documentation.
f.)
The authorisation holder can demonstrate the quality of the medicinal product at any time if so requested by Swissmedic using the documentation on manufacture and analytical, chemical and pharmaceutical testing.
If only letters b to d are not fulfilled, it may be possible to apply for authorisation of a medicinal product without indication with “complete dossier” in accordance with Art. 25 para. 2. For more information refer to the section: Simplified authorisation without indication “complete dossier”.
The following documents in particular should be noted for the authorisation: