TPA2: New features of the «Lozenges» list (Annex 5, KPAV)

Cough and throat lozenges and pastilles may be approved through the notification procedure. With the launch of the new Therapeutic Products Act on the 1^st of January 2019, a basic company dossier will, for the first time, have to have been approved beforehand. Such products may only contain active substances, which are covered by the basic company dossier and which are listed in the «Lozenges» list (Annex 5, KPAV). Compared to the list of permitted active substances in force until the end of 2018, a few herbs, which no longer meet today’s requirements, have been removed from the new «Lozenges» list. Medicinal products containing active substances, which are not contained in the «Lozenges» list have to be approved via the simplified approval procedure (this also applies in cases where no basic company dossier is available). This means that Modules 3-5 have to be submitted, with Modules 4 and 5 thereby being able to be based on literature data. Preparations already approved, which, according to the new legislation, contain active substances which are no longer permitted, are not affected by this reform.