Single teas can be authorised in a notification procedure on the basis of Art. 15 para. 1 let. b TPA (SR 812.21). Art. 12 KPTPO (SR 812.212.24) restricts as follows the options for authorising teas on the basis of a notification:
Teas can be authorised by Swissmedic on the basis of a notification provided:
a. they are single teas containing a drug listed in Annex 4 KPTPO (“Tea drugs” list);
b. they are listed for an indication on the “Tea drugs” list;
c. they can be assigned to dispensing category E.
If single teas are intended to be authorised in a notification procedure, an approved basic company dossier must be available (Art. 37 and 38 KPTPO).
The mandatory information in accordance with Annex 4 KPTPO (“Tea drugs” list) must appear on the packaging elements. Only the wording in the Annex may be used as the health claim (indication) and the dosage recommendation must also be stated in the same way. The notified single tea is intended exclusively for use by adults.
The dosage form is “herbal tea” in accordance with the EDQM Standard Terms.
The drugs used as active substances must comply with the quality requirements of the respective Ph. Eur. or Ph. Helv. monographs.
Single teas which do not fulfil the above criteria and tea mixtures can be authorised as herbal medicinal products in the simplified procedure stipulated in Art. 14 let. cbis TPA.