| Type | Description | Euros |
|---|---|---|
| 5.01 | Fee for the evaluation of a first clinical trial with medicines 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 | 4.414,24 |
| 5.02 |
Fee for the evaluation of: a) A clinical trial with a medicine that is authorised in a country other than Spain that belongs to the International Conference on Harmonisation (ICH) b) Clinical trials with medicines that are not authorised in any country belonging to the International Conference on Harmonisation (ICH), following a first clinical trial included in the category 5.1 c) Clinical trials with the characteristics outlined in 5.1 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 International Conference on Harmonisation (ICH), with active substances that are authorised in Spain |
420,40 |
| 5.03 |
Fee for the evaluation of: a) Clinical trials with medicines 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 |
116,86 |
| 5.04 | Procedure for classifying a veterinary medicine that is not authorised in Spain as investigational medicinal product | 289,46 |
| 5.05 | Fee for the veterinary clinical trials procedure | 116,86 |
Fees Group V
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List of types of fees > Fees Group V