New features of the notification approval procedure for lozenges

New features of the notification approval procedure for List E lozenges resulting from TPA2

The revision of the Therapeutic Products Act has resulted in changes to the approval of dispensing category E cough and throat lozenges: (1)Flavourings may continue to be declared as before,but declarable substances have to be listed qualitatively and quantitatively pursuant to Annex 3a AMZV (= Ordinance of the Swiss Agency for Therapeutic Products on the Requirements for the Authorisation of Medicinal Products). (2) Different to before, the maximum content per unit has to be declared and justified for essential oils. This rationale may be referenced in the cover letter. (3) In relation to manufacturers’ information, the basic company dossier only needs to be updated if manufacturers’ information changes, but not if a GMP certificate has run out. The manufacturers only need to be listed once per section in the form «Manufacturer Information». Information as to which active substance these manufacturers produce does not need to be provided.

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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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