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 € |