A complete dossier in accordance with Art. 25 let. 2 containing the documentation stipulated in Annex 3 KPTPO and the quality and safety documentation stipulated in Annex 2 KPTPO must be submitted to Swissmedic for the simplified authorisation of a homeopathic or anthroposophic medicinal product without indication that is not intended for authorisation exclusively under a designation shown in Annex 1a para. 1 let. a of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Licensing of Complementary and Phytotherapeutic Products (KPTPO) or with a dosage recommendation.
The following conditions apply to the authorisation of a medicinal product without indication in accordance with Art. 25 para. 2 and Art. 26 para. 1 KPTPO:
a) In accordance with Annex 1a para. 1 let. j, no reference may be made to the indication.
b) The name of the medicinal product may, for example, contain the name of the company or a creative name but may not suggest an indication.
c) Information for patients in accordance with Annex 3 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO) must be produced using the prescribed wording for Art. 25 para. 2 KPTPO.
d) If the intention is to state a dosage recommendation, this must be substantiated with meaningful documentation.
The following documents in particular should be noted for the authorisation: