CASubmissionFee object
Fees for trial submission mandatory
Yes
Fees
Application fee for authorisation to conduct clinical trials:
45.000 SEK (~ € 5.000)
Waiver for academic (non-commercial) studies possible
Yes
Official guidance on required fees
Payment requirements and unofficial English version of the applicable Ordinance (SFS 2010:1167) concerning fees are available on MPA website > Medicinal Products > Fees.
Applicable national legal framework/ Reference
Source: SFS 2010:1167 Ordinance concerning fees for the governmental control of medicinal products