Threshold levels and their significance in relation to the declaration of excipients of particular interest.
The threshold levels listed in Annex 3a of the AMZV [Ordinance of the Swiss Agency for Therapeutic Products on the Requirements for the Authorisation of Medicinal Products (Medicinal Products Authorisation Ordinance)] specify which concentration/quantity of a given excipient make it an «excipient of particular interest». The following rule thus applies:
If an excipient in Annex 3a AMZV lies below the threshold specified therein or if the route of administration specified does not apply, it is considered to be a normal excipient (both warnings and declarations on the packaging as well as quantitative declarations in the Information for Healthcare Professionals may thus be omitted).
