Revista Farmabiotec Número 25

24 farmaBIOTEC #25 Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (final compromise text dated on 19/02/2026 and published on March 2026). Disponible en https://data. consilium.europa.eu/doc/document/ST-6366-2026-INIT/ en/pdf (acceso 02.05.26) • 3. Real Decreto 477/2014, de 13 de junio, por el que se regula la autorización de medicamentos de terapia avan- zada de fabricación no industrial. Acceso en https://www. boe.es/diario_boe/txt.php?id=BOE-A-2014-6277 Red TERAV Considerando 18 de la Directiva 18. Advanced therapy medicinal products (ATMPs) prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual me - dical prescription for a custom-made product for an individual patient, should be subject to an exemption from the general requirements set in this Directive and the [revised Regulation (EU) No. 726/2004], while ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are significant variations in the implementation of hospital exemption among Member States. To improve the implementation of the hospital exemption, this Directive introduces measures for collection, reporting of data as well as re - view of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should prepare a report on the implementation of hospital exemption based on contributions fromMember States to assess whether an adapted framework should be developed for certain less complex ATMPs that have been developed and used under the hospital exemption. When an approval for the manufacturing and use of an ATMP under hospital exemption is revoked due to safety concerns, the relevant competent authorities should notify the Agency, which should then disseminate this information to the other Member States' competent authorities. Artículo 2 de la Directiva Article 2 Advanced therapy medicinal products prepared under hospital exemption 1. By way of derogation fromArticle 1(1), only this Article shall apply to advanced therapy medicinal products prepared within the Member State on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the ex - clusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product to meet the needs of an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). 2. The manufacturing and use of an advanced therapy medicinal product prepared under hospital exemption shall require an approval by the competent authority of the Member State (‘hospital exemption approval’). Member States shall notify any such approval, as well as subsequent changes, to the Agency. The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is loca - ted. 3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equi - valent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/2007 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. 4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption as well as any relevant data specified in the implemented acts referred to in paragraph 7, is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The data shall be collected and reported in a structured and standardised way that enables robust, reliable and comparable results and conclusions. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3. Upon request, the competent authorities shall provide scientific and regulatory advice to developers of advanced therapy medicinal products to be prepared and used under hospital exemption and to hospital exemption approval holders on the further development of their advanced therapy medicinal product, and when appropriate for the purpose of obtaining a marketing authorisation by the Union. 5. If a hospital exemption approval is revoked due to safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency. The Agency shall inform the competent authorities of the other Member States. 6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, including the mechanism for electronic submission. 7. The Commission shall adopt implementing acts to specify the following: (a) details of the application for the approval of hospital exemption referred to in paragraph 2, second subparagraph, including the evidence on quality, safety and efficacy of the advance therapy medicinal products prepared under hospital exemption for the approval and the subsequent changes; (b) the content and format for collection and reporting of data referred to in paragraph 4; (c) the modalities for the exchange of knowledge between hospital exemption approval holders within the same Member State or different Mem - ber States; (d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contri - butions fromMember States and the data referred to in paragraph 4. The report shall be made publicly available. The first report shall be provided three years after [date =24 months after the date of entering into force of this Directive] and then every five years thereafter. Texto de la nueva directiva europea (ref 1) que regula la exención hospitalaria para los medicamentos de terapia avanzada.