Cough and throat lozenges and pastilles can be authorised on the basis of a notification pursuant to Art. 15 para. 1 let. b TPA (SR 812.21). Art. 13 KPTPO (SR 812.212.24) restricts as follows the options for authorising cough and throat lozenges and pastilles on the basis of a notification:
Cough and throat lozenges and pastilles can be authorised by Swissmedic on the basis of a notification provided they contain exclusively the following components:
- Plants, plant parts or plant preparations listed in Annex 5 KPTPO (“Lozenges” list),
- Aromatic substances or colouring agents that are also used to manufacture sweets in accordance with food legislation,
- Essential oils within the prescribed content limits according to Annex 5 KPTPO,
- Synthetically manufactured or chemically defined substances listed in the “Lozenges” list;
Any excipients used must comply with the requirements of the pharmacopoeia or other pharmacopoeias recognised by Swissmedic provided relevant requirements are stated.
Only indications listed in the “Lozenges” list (Annex 5 KPTPO) may be requested. Furthermore, it must be possible to assign the medicinal product to dispensing category E.
The submission of the application (notification) is based on Art. 3 TPO (SR 812.212.21) in conjunction with Art. 32 TPLO (SR 812.212.23) and Chapter 7 of the KPTPO.
The requirements of the TPLRO (SR 812.212.22) apply to information and texts on containers and packaging materials.