Tasas

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.