Information on Variation Application Fee Capping
Swissmedic has introduced the principle of capping in response to the rise of fees for variations with revision of the law and so the following should be noted:
(1) To determine caps, the current Ordinance on Fees is always decisive. It is irrelevant whether authorisation of the medicinal product took place before or after the revision of the Ordinance on Fees.
(2) Should the authorisation category, for example, NA-NAS, KAS with / without innovation, major variation / new pharmaceutical form of the medicinal product not be clear, Swissmedic (Case Manager) can investigate the issue. The same applies to medicinal products. In particular, the authorisation categories that did not yet exist at the time of authorisation or where the categorisation was different, for example, 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. Discounts given based on Art. 13 or Orphan Drugs do not factor into the capping process.
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