Rates

Article 121. Exemptions.

1. The provision of services or carrying out activities relating to the manufacture of “medicinal products without commercial interest” referred to in Article 3.3 shall be exempt.
2. Services and activities shall be exempt for modifications to the conditioning material aimed at making the printing in braille language effective, in accordance with the provisions of Articles 15.5 and 31.5.
3. Services and activities related to advanced therapy drugs that are not intended for marketing carried out by entities of a public nature integrated in the National Health System, as well as the services of scientific advice and clinical studies that are not intended for the realization of profit-making activities will be exempt from the corresponding fee.
4. Modifications of authorizations and/or registers granted by the Spanish Agency for Medicines and Medical Devices will be partially exempt from the payment of the corresponding fee when they necessarily derive from the approval, by regulatory rule, of a new general regulation. The rate will be reduced by ninety-five percent of the amount established in each case.
5. Holders who submit new applications for authorization and/or registration or their modifications will be partially exempt from the corresponding fee when, for reasons of health interest, the Spanish Agency for Medicines and Health Products or the European Commission requests their authorization and/or registration or modification. The rate will be reduced by ninety-five percent of the amount established in each case.
6. the European Parliament and Council Regulation (EU) 2019/6 of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC, an exemption from 70% of the fees for marketing authorisations, amendments to the marketing authorisation requiring evaluation, scientific advice, products at the stage of veterinary clinical research, veterinary clinical trials, post-authorisation studies, official batch release certificates pursuant to Articles 127 and 128 of the European Parliament and Council Regulation (EC) No. The exemption provided for in this paragraph shall not apply to the transfer of ownership procedure.
7. Clinical studies that correspond to the definition of “non-commercial clinical research” according to article 2.2.e) of Royal Decree 1090/2015, of 4 December, which regulates clinical trials with medicines, the Committees of Ethics of Research with medicines and the Spanish Registry of Clinical Studies, will be exempt from fees.

Similarly, in the new Law, for the purposes of the amount of the fee, the term “tax” shall be understood to mean line extension the second and successive applications for authorisation and registration in the register of other pharmaceutical forms, routes of administration and concentration of a medicinal product already authorised and registered.

The amount of the line extension fee will be seventy percent of the drug’s first authorization. In the case of medicinal products for veterinary use, the extension of an authorisation to new target species shall be considered as an extension of the line, provided that they are food-producing species.

Amendments requiring the submission of a new application for authorisation, in accordance with the European standard governing amendments to the authorisation of medicinal products granted by the competent authority of a Member State, shall constitute an extension of the line.