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List of types of fees

Inicio > AEMPS > Tasas > List of types of fees
Last update: June 28th, 2023
Rate Description Amount
1.01 Authorization and registration of full dossier 17.073,00 €
1.02 Authorization and registration of an abbreviated dossier 8.736,33 €
1.03 Authorization and registration of a simplified dossier 1.131,59 €
1.04 Ownership transfer of the authorization of a medicinal product for human use, or by modification of the owner’s representative 436,94 €
1.05 Modification of a marketing authorisation type II 3.509,06 €
1.06 Modification of a marketing authorisation type IB 2.008,86 €
1.07 Modification of a marketing authorisation simplified dossier 331,09 €
1.08 Annual fee for Initial maintenance of medicinal products authorized by complete dossier 1.711,71 €
1.09 Annual fee for medicinal products authorized by abbreviated dossier or medicinal products authorized by full dossier when the authorization exceeds ten years 855,85 €
1.10 Simple annual maintenance fee for medicinal products authorized by simplified dossier 171,17 €
1.11 Parallel import of a medicinal product for human use 531,87 €
1.12  Authorization modification of a parallel import for a medicinal product for human use 265,93 €
1.13  Issuance of European or national certificate of batch release for vaccines or blood products for human use 1.335,97 €
1.14  Acknowledgement of a batch release certificate and authorization to place on the national market a batch of vaccines or blood products 84,76 €
1.16  Recognition of a batch release certificate and authorization to place a batch of vaccines or blood products on the national market (between and releases per year) 423,78 €
1.16  Recognition of a batch release certificate and authorization to place a batch of vaccines or blood products on the national market (between and releases per year) 1.271,35 €
1.17  Recognition of a batch release certificate and authorization to place a batch of vaccines or blood products on the national market (between and releases per year) 2.966,47 €
1.18  Recognition of a batch release certificate and authorization to place a batch of vaccines or blood products on the national market (more than releases per year) 4.237,82 €
1.19  Issuance of European or national batch release certificate for bulk vaccine or plasma mixture 534,39 €
1.20  Export authorization of narcotic medicinal products and psychotropic medicinal products to intra-community countries and third countries 97,97 €
1.21  Bulk allergens 877,27 €
1.22  Reserve a vacancy for Spain to act as the Reference Member State in a decentralized, mutual recognition or repeat use procedure 853,65 €
Rate Description Amount
2.01   Evaluation of a clinical trial of a medicinal product for human use not authorized in the EU 5.741,27 €
2.02   Evaluation of a clinical trial of a medicinal product for human use authorized in the EU 3.611,07 €
2.03   Substantial modification of a clinical trial of a medicinal product for human use 1.764,71 €
2.04   Procedure for the qualification as an investigational medicinal product (IMP) of a veterinary medicinal product not authorized in Spain 669,42 €
2.05   Authorization of a veterinary clinical trial (VCT) 502,07 €
2.06   Authorization of a veterinary post-authorization study (EPA) 502,07 €
2.07   Modification of an IMP/VCT/EPA 200,83 €
Rate Description Amount
3.01   Authorization procedure for the opening of a pharmaceutical laboratory 9.418,23 €
3.02   Authorization for the opening of a pharmaceutical laboratory by transfer of ownership without an inspection visit 468,32 €
3.03   Procedure for modifying the authorization of a pharmaceutical laboratory due to minor changes in the authorization 187,33 €
3.04   Procedure for modifying the authorization of a pharmaceutical laboratory due to major changes or modification of the registration of manufacturing, importing or distributing companies of active ingredients, when the inspections do not include an inspection visit 5.838,26 €
3.05   Procedure for modifying the authorization of a pharmaceutical laboratory due to major changes or modification of the registration of manufacturing, importing or distributing companies of active ingredients, when the inspections include an inspection visit 8.279,15 €
3.06   Individualized inspection actions, excluding complaints or at the request of a representative users’ or consumers’ association at the national level 9.137,23 €
3.07   Individualized inspection actions, excluding complaints or at the request of a representative users’ or consumers’ associations in third countries 20.772,11 €
3.08   Manufacturing authorization for medicinal products approved in other countries and not registered in Spain 468,32 €
3.09   Authorization for the exceptional manufacture by third parties of medicinal products for human and/or veterinary use 383,08 €
3.10  Authorization or modification due to major changes and/or certification of medicinal product warehouses under customs control or surveillance 2.258,30 €
3.11  Minor change modification in the authorization of medicinal product warehouses under customs control or surveillance 187,33 €
3.12  Authorization to cultivate plants that may be used in the manufacturing of narcotic medicinal products and psychotropic substances 2.449,36 €
3.13  Initial registration, notification of mandatory modifications or annual update of the register of manufacturers, importers or distributors of active ingredients 468,32 €
3.14  Inscription in the registry of persons engaged in the intermediation of the distribution of medicines for human use or modification of the inscription 468,32 €
Rate Description Amount
4.01   Issuance of a certification at the request of a party
4.02   National scientific/regulatory advice for medicinal products for human use that includes a specific issue Simple Advice
4.03   National scientific/regulatory advice for medicinal products for human use that includes multiple issues Complex Advice
4.04   National scientific/regulatory advice for generic medicinal products for human use
4.05   Follow-up national scientific/regulatory advice (within the same year of the initial consultancy)
4.06   Scientific/regulatory advice related to veterinary medicinal products
4.07   Scientific/technical advice on the design of manufacturing facilities and processes in accordance with good manufacturing practices
4.08   Scientific/technical advice on the application for authorization to cultivate plants that may be used in the manufacturing of narcotic medicinal products and psychotropic substances
4.09   Scientific/technical advice on authorizations, facilities and processes for the manufacture or importation of repellents or disinfectants for clinical and personal use, and on authorizations for personal care products
Rate Description Amount
5.01   Registration and reporting of medical devices 99,71 €
5.02   Registration procedure and individualized authorization or revalidation of personal care products, biocides for human hygiene, sanitary surface disinfectants, and insect repellents for human use 918,95 €
5.03   Procedure for the modification of an application for registration of personal care products, biocides for human hygiene, sanitary surface disinfectants and insect repellents for human use 367,58 €
5.04   Procedure for issuing a certification (in certifications of cosmetic products, personal care products and biocidal products for human hygiene, sanitary surface disinfectants and insect repellents for human use, up to a maximum of products per certification) and procedure for issuing certificates of compliance with good manufacturing practices for cosmetic products 173,04 €
5.05   Verification and control procedure for the declaration of responsibility for the manufacturing activity of cosmetic and personal care products 932,46 €
5.06   Verification and control procedure for the declaration of responsibility for the importation of cosmetic and personal care products 466,23 €
5.07   Verification and control procedure for the declaration of responsibility for substantial modifications of the manufacturing activities of cosmetic and personal care products 466,23 €
5.08   Verification and control procedure for the declaration of responsibility for substantial changes in the import activities of cosmetic and personal care products 279,74 €
5.09   Individualized inspection actions for the verification of the declaration of responsibility for cosmetics and personal care products manufacturing activities 837,18 €
5.10  Individualized inspection actions for the verification of the declaration of responsibility for activities for the importation of cosmetics and personal care products 418,59 €
5.11  Preliminary operating license for manufacturing establishments of biocides for human hygiene, sanitary surface disinfectants and insect repellents for human use 1.205,95 €
5.12  Preliminary operating license for establishments importing and/or storing biocides for human hygiene, sanitary surface disinfectants and insect repellents for human use 602,98 €
5.13  Modification or revalidation of a previous operating license for establishments manufacturing biocides for human hygiene, sanitary surface disinfectants and insect repellents for human use with respect to their location 1.205,95 €
5.14  Modification or revalidation of a previous operating license for the importation and/or storage of biocides for human hygiene, sanitary surface disinfectants and insect repellents for human use with respect to its location 602,98 €
5.15  Minor modification of the previous license to operate establishments of biocides for human hygiene, sanitary surface disinfectants and insect repellents for human use 301,49 €
5.16  Individualized inspection actions for the verification of good manufacturing practices for cosmetic products 837,18 €
5.17  Preliminary operating license for medical device manufacturing, sterilization and reprocessing establishments 983,85 €
5.18  Preliminary license for the operation of establishments for the import and grouping of medical devices 491,92 €
5.19  Modification or revalidation of a previous operating license for manufacturing, sterilizating and reprocessing establishments of medical devices 983,85 €
5.20  Modification or revalidation of a previous operating license of an importing establishment or grouping of medical devices 491,92 €
5.21  Minor modification of the previous license to operate medical device establishments 245,96 €
5.22  Authorization of clinical investigations of medical devices and performance evaluation studies of in vitro diagnostic medical devices 1.553,51 €
5.23  Substantial modification authorization of a clinical investigation of medical devices and performance evaluation studies of in vitro diagnostic medical devices 543,73 €
5.24  Import authorization of raw materials of human origin for the manufacture of in vitro diagnostic medical devices 87,40 €
5.25  Annual fee for maintenance of product information reported to the marketing registry 59,83 €
Rate Description Amount
6.01   Application for marketing authorization of a veterinary medicinal product, except for the applications referred to in article of Regulation (EU) No / of the European Parliament and of the Council, of December , 15.573,55 €
6.02 Application for a marketing authorization for a veterinary medicinal product referred to in Article of Regulation (EU) / of the European Parliament and of the Council of December 6.478,35 €
6.03   Application for special simplified registration of a veterinary medicinal product 1.172,82 €
6.04   Procedure for the transfer of ownership of a veterinary medicinal product 395,30 €
6.05 Variation to a marketing authorisation requiring assessment (VRA) 4.962,48 €
6.06 Modification of a marketing authorisation simplified dossier and parallel trade 566,47 €
6.07   Authorization procedure for parallel trade of a veterinary medicinal product 1.385,15 €
6.08   Annual maintenance fee for an authorized veterinary medicinal product 764,26 €
6.09   Annual maintenance fee for a veterinary medicinal product registered by special simplified procedure and authorized for parallel trade 152,85 €
6.10  Issuance of European certificate of official batch release for immunological veterinary medicinal products according to Article of Regulation (EU) / of the European Parliament and of the Council of December 422,47 €
6.11  Issuance of European certificate of official batch release for immunological veterinary medicinal products according to Article of Regulation (EU) / of the European Parliament and of the Council of December 1.335,97 €
6.12  Reserve a vacancy for Spain to act as the reference Member State in a decentralized, mutual recognition and subsequent recognition procedure 414,88 €
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 €