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Fees Group IX

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Type Description Euros
9.01 Fee for applying for market authorisation for a veterinary medicinal product (VMP), except for applications outlined in article 17.3 10.788,17
9.02 Fee for applying for market authorisation for a generic VMP (file issued in accordance with article 17.3) 4.388,33
9.03 Fee for transfer of a marketing authorisation of a VMP, or for changing the local representative 733,16
9.04 Fee for the procedure of modifying the authorisation for VMP, classified as “major importance” Type II 3.705,72
9.05 Fee for the procedure of modifying the authorisation for VMP, classified as Type IB 1.274,45
9.06 Fee for the procedure of modifying the authorisation for VMP, classified as type IA (including those type IA with immediate notification) 753,83
9.07 Fee for the authorisation of the renewal procedure for a VMP 2.437,84
9.08 Annual single fee for declaring an intention of commercialisation of an already-authorised VMP 125,08
9.09 Fee for the authorisation procedure for the “parallel importing” of a VMP 768,93
9.10 Fee for assessment of the six-monthly safety report of a VMP, whether or not the product is registered in Spain 398,25
9.11 Fee for assessment of the annual safety report of a veterinary medicine, whether or not the product is registered in Spain 788,61
9.12 Fee for assessment of the three-yearly or longer safety report of a VMP, whether or not the product is registered in Spain 2.365,84
9.13 Fee for issuing European certification for the formal batch release of an immunological VMP in accordance with article 81 of Directive 2001/82/EC 353,14
9.14 Fee for issuing European certification for the formal batch release of an immunological VMP in accordance with article 82 of Directive 2001/82/EC 1.261,21
9.15 Fee for reserving a slot for Spain to act as the Reference Member State in a Decentralised or Mutual Recognition procedure 420,40