| 1.01 |
Fee for the evaluation, authorisation and registration of a new medicine for human use (application in accordance with article 17, with the exception of the provision in 17.3) |
21.576,36 |
| 1.02 |
Fee for the evaluation, authorisation and registration of a new generic medicine for human use (application in accordance with article 17.3) |
8.776,68 |
| 1.03 |
Fee for the evaluation, authorisation and registration of a new medicinal gas |
8.776,68 |
| 1.04 |
Fee for changing the ownership of a marketing authorisation for a medicine for human use, or for changing the owner’s representative |
733,16 |
| 1.05 |
Fee for the variation of a marketing authorisation for medicines for human use, classified as of «major importance» Type II |
7.411,44 |
| 1.06 |
Fee for the variation of a marketing authorisation for medicines for human use, classified as Type IB |
1.299,94 |
| 1.07 |
Fee for the variation of a marketing authorisation for medicines for human use, classified as type IA (including those of type IA with immediate notification) |
753,83 |
| 1.08 |
Fee for the renewal application for a medicine for human use |
2.437,84 |
| 1.09 |
Annual fee for the maintenance of an already-authorised medicine for human use |
388,88 |
| 1.10 |
Fee for the authorisation procedure for a «parallel imported» medicine for human use |
942,21 |
| 1.11 |
Fee for the variation for a «parallel imported» medicine for human use |
381,37 |
| 1.12 |
Fee for the renewal for a «parallel imported» medicine for human use |
381,37 |
| 1.13 |
Fee for the notification of an imported medicine for human use |
373,62 |
| 1.14 |
Fee for issuing an European certification for the batch release of vaccines and blood products for human use when the batch-analysis of a medicine is required |
1.261,21 |
| 1.15a |
Fee for the batch release of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October: (a) each individual application |
105,10 |
| 1.15b |
Fee for the batch release of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October: (b) between 6 and 10 applications/year (per year) |
525,51 |
| 1.15c |
Fee for the batch release of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October: (c) between 11 and 40 applications/year (per year) |
1.576,52 |
| 1.15d |
Fee for the batch release of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October: (d) between 41 and 160 applications/year (per year) |
3.678,54 |
| 1.15e |
Fee for the batch release of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October: (e) for more than 160 applications/year (per year) |
5.255,05 |
| 1.16 |
Fee for issuing an European certification for the batch release of vaccines and blood products for human use when a bulk-analysis is required (by bulk) |
353,14 |
| 1.17 |
Fee for the evaluation of an application for a galenic innovation |
1.024,00 |
| 1.18 |
Authorisation to export narcotic and psychotropic medicines to EU countries and third countries |
178,67 |
| 1.19 |
Fee for the activities outlined in section 6 of article 11 |
381,37 |
| 1.20 |
Fee for reserving a slot to act as the Reference Member State in a Decentralised or Mutual Recognition Procedure |
788,26 |
