Information about the capping of fees in the case of multiple variation applications
Given that the fees for variations have risen with the revision of the law, Swissmedic has introduced the principle of capping. The following should be noted in this regard: (1) For the purposes of determining caps, the prevailing Ordinance on Fees is always decisive. It is irrelevant whether the medicinal product was authorised prior to or after the revision of the Ordinance on Fees. (2) Should the authorisation category (e.g. NA-NAS, KAS with/without innovation, major variation/new pharmaceutical form, …) of the medicinal product not be clear, then this can be inquired from Swissmedic (Case Manager). This also applies to medicinal products, for which these authorisation categories did not yet exist at the time of initial authorisation or for which the categorisation was different (e.g. KAS with/without innovation classification). (3) Caps always refer to the flat-rates. Surcharges and discounts (FTAP, PPN, Art. 13, Art. 14) are not applicable, i.e. discounts given on the basis of Art. 13 or Orphan Drugs are not factored into the capping process.