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Fees Group I 

Inicio > List of types of fees > 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