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Tasas

SEDE AEMPS > Tasas

The manual for the telematic payment of fees, in its version 2.1, updated until July 25, 2023, provides the necessary instructions to carry out the payment of fees of the headquarters electronically, and will be made through the following application.

The use of the fee payment application is regulated by the Royal Legislative Decree 1/2015, of July 24, which approves the revised text of the Law on Guarantees and Rational Use of Medicines and Health Products). Art. 125.1.

Article 125.2 of Royal Legislative Decree 1/2015, of July 24, which approves the rewritten text of the Law on Guarantees and Rational Use of Medicines and Health Products states that «In the case of self-assessments of fees made by the taxpayer, applications shall be submitted at the latest, within a period of one month since the payment was made. In the case of liquidations of fees practiced by the General State Administration regarding medicines, medical devices, cosmetic products and personal care products, the payment shall be made at the latest, within twenty days from the notification of the liquidation to the interested party.»

Possible applicable exemptions

Article 121. Exemptions.

  1. The rendering of services or performance of activities related to the manufacture of «medicines without commercial interest» referred to in article 3.3 shall be exempted.
  2. The services and activities for modifications in the packaging material that have as object to make effective the impression in Braille language, in accordance with the foreseen in articles 15.5 and 31.5, shall be exempt.
  3. The services and activities related to advanced therapy drugs that are not intended for commercialization carried out by public entities integrated in the National Health System, as well as the scientific consultancy services and clinical studies that are not intended for profit-making activities, shall be exempt from the payment of the corresponding fee.
  4. Modifications of authorizations and/or registrations granted by the Spanish Agency of Medicines and Health Products will be partially exempted from the payment of the corresponding fee when they necessarily derive from the approval, by regulatory norm, of a new general regulation. The fee will be reduced by ninety-five percent of the amount established in each case.
  5. The holders who submit new applications for authorization and/or registration or their modifications when, for reasons of health interest, the Spanish Agency of Medicines and Health Products or the European Commission requests their authorization and/or registration or modification, will be partially exempted from the payment of the corresponding fee. The fee will be reduced by ninety-five percent of the amount established in each case.
  6. It shall apply to veterinary medicinal products intended exclusively for limited markets and to the species included in points (c) and (d) of Article 39. 1 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC a seventy percent fee exemption for marketing authorizations, marketing authorization variations requiring evaluation, scientific advice, products undergoing veterinary clinical investigation, veterinary clinical trials, post-authorization studies, official batch release certificates according to Articles 127 and 128 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018, maintenance on the market of veterinary medicinal products authorized by national, mutual recognition or decentralized procedure, as well as to the procedures for re-examination and harmonization of the summaries of the characteristics of veterinary medicinal products provided for in Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018. The exemption provided for in this paragraph shall not apply to the procedure for transfer of ownership.
  7. Clinical studies that correspond to the definition of «non-commercial clinical research» in accordance with article 2.2.e) of Royal Decree 1090/2015, of December 4, 2015, which regulates clinical trials with drugs, the Ethics Committees for Research with drugs and the Spanish Registry of Clinical Studies, will be exempt from payment of fees.

Likewise, in the new Law, for the purposes of the amount of the fee, a line extension will be understood as the second and successive applications for authorization and registration in the registry of other pharmaceutical forms, routes of administration and concentration of a drug already authorized and registered.

The amount of the fee for line extensions will be seventy percent of the first authorization of the medicinal product. In the case of veterinary medicinal products, the extension of an authorization to new target species will be considered as a line extension, provided that they are food-producing species.

Those modifications that require the presentation of a new application for authorization, in accordance with the European rule that regulates the modifications of the authorization of medicinal products granted by the competent authority of a Member State, will constitute a line extension.

Instructions for payment by wire transfer

The account number for payment by bank transfer is:

IBAN: ES57 2100 8981 6102 0000 5869
SWIFT: CAIXESBBXXX

The payment can be made in two ways, being more advisable the first method:

  • For the payment of a single voucher by bank transfer:
    In the concept of the bank transfer must be specified only the thirteen-digit model 317 number previously filled in. No further information is required. Only 13 characters.
    Correct: 3170004700947
    Incorrect: ZUCBZ3130200000070592024+++317000470094. In this case there would be too many characters and the voucher no. could not be read.
  • Payment of several receipts in a single transfer:
    In the concept of the bank transfer, only the last three digits of each voucher paid must be specified in the concept. There is no need to add further information. For example, if I pay the vouchers: 3170000000455, 3170000000456 y 3170000000457, in the concept you should specify the number of the first voucher and the last three digits of the following paid vouchers.
    Correct: 3170000000455,456 y 457
    Incorrect: 3170000000455,  3170000000456 y 3170000000457. In this case there would be excess characters and the voucher numbers could not be read.
    Inform tasasydevoluciones@aemps.es referring to the paid 317 forms.

If these instructions are not followed we do not ensure the correct validation of the payment.

Important! Before paying, check if you must pay through the applications or through the following link. If in doubt, please refer to point 2 of the manual for telematic payment of fees.