Fees for the examination of new applications, amendments and reports for clinical trials are based on the current version of the Ordinance on the Fees charged by the Swiss Agency for Therapeutic Products (version dated 1 January 2023). The link to this ordinance is given below.
Sponsors of clinical trials with medicinal products, medical devices and novel therapies that are not financed by commercial third-party funding may apply for a fee reduction. Fees will be reduced by 80% for the processing of applications and reports in the context of such clinical trials. Further information and application: Submission of applications
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For administrative actions in the context of its supervisory duties, Swissmedic levies charges that are calculated either on the basis of the flat fees set out in Annexes 1 and 2 of the Ordinance on the fees charged by the Swiss Agency for Therapeutic Products (Fee Ordinance-Swissmedic; SR 812.214.5) or according to the actual work incurred (Art. 4 para. 1 FeeO-Swissmedic). Any additional work incurred shall be invoiced in addition as per Art. 5 FeeO-Swissmedic. The fees are payable by the entity that requested the administrative action (Art. 3 para. 1 FeeO-Swissmedic). By submitting an application you accept these fees. |
