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AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS

Fees Group VI

Inicio > List of types of fees > Fees Group VI
Type Description Euros
6.01 Authorisation of a new pharmaceutical laboratory 6.156,58
6.02 Minor changes to a pharmaceutical laboratory authorisation 342,37
6.03a Major changes to a pharmaceutical laboratory authorisation, when the inspection activities do not include an inspection visit 4.054,56
6.03b Major changes to a pharmaceutical laboratory authorisation, when the inspection activities include an inspection visit 6.156,58
6.04a Individual inspection activities in Spain, unless a complaint has been made or it is requested by a representative association of consumers 5.208,19
6.04b Individual inspection activities in third countries, unless a complaint has been made or it is requested by a representative association of consumers 11.350,91
6.04c Individual inspection activities, in third countries, non-mandatory, requested by the interested party 21.020,20
6.05 Authorisation for the manufacturing process of medicines approved in other countries but not authorised in Spain 669,34
6.06 Exceptional manufacturing authorisation by a third party of medicines for human and/or veterinary use 342,37
6.07 Authorisation and/or certification for medicines warehouses under customs control or supervision 1.366,31
6.08 Decision to authorise the cultivation of plants that can be used for manufacturing narcotics and psychotropic medicines 630,61
6.09 Initial registration, notification of mandatory changes or annual updating of the registry of manufacturers, importers or distributors of active substances 840,81
6.10 Registration of Brokers of medicines for human use 262,76