CASubmissionFee object

Yes

(1)
A first clinical trial with MPs that are not authorised in a country that belongs to the International Conference on Harmonisation (ICH) with active substances or combinations of active substances that are not authorised in Spain:
Fee: €4327.26
(2)
a) A clinical trial with a MP that is authorised in a country other than Spain (belonging to the ICH).
b) Clinical trials with medicines that are not authorised in any country belonging to the ICH, following a first clinical trial included in the category (1)
c) Clinical trials with the characteristics outlined (1) in the event of resubmission when the outcome of the first application was a withdrawal of the application or was refused
d) Clinical trials with a medicine that is not authorised in a country belonging to the ICH with active substances that are authorised in Spain.
Fee: € 412.12
3)
a) Clinical trials with MP authorised in Spain, irrespective of their specific labelling for the trial.
b) Clinical trials whose sponsor is a researcher or group of researchers and in which a Pharmacy Service is responsible for preparing or blinding the medicines under investigation
Fee: € 114.55
(4)
Procedure for classifying a veterinary medicine that is not authorised in Spain as investigational medicinal product. Fee: € 283.76
5)
Fee for the veterinary clinical trials procedure. Fee: € 114.55

Reduced fees are charged

The current fees and payment modalities are provided on the AEMPS website: Medicines for human use>Clinical research with medicines > Tasas/Fees