Simplified authorisation without indication “complete dossier”

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:

Last modification 11.08.2022

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