Fees Group I

Type	Description	Euros
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