The Swedish Medicines Agency (MPA) is proposing increases in fees
On March 2, 2021, the MPA has proposed to the Swedish government an increase in fees for control of medicinal products as of January 1, 2022. The reason for the increases is mentioned e.g. increase in operating costs.
According to the MPA, the increases would cover a wide range of control tasks, including the assessment marketing authorization applications and type II variation applications for the addition of an indication. The proposed fee increases are partly significant, especially for clinical trials (HUM: +200%, VET: +500%) and marketing authorization procedures for veterinary medicines (+ 50-100%), as well as for application fees for homeopathic products and parallel imported veterinary medicines. Increases in marketing authorizations for medicinal products for human use would be more moderate, but a 20% increase is proposed for national marketing authorization application fees for national procedures and a 25% increase for MRP / DCP processes where Sweden is a participating Member State (CMS). The annual fee for human medicines, on the other hand, would increase by about 20%.
The proposed increases are specified in Annex 3 of the MPA proposal.