SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
(or a link to the one issued by the EMA), as well as the summary of product characteristics (SmPC), the patient leaflet and any other relevant information (risk management of the product, usage restrictions, post- authorisation studies, etc). All this information is included in a publicly accessible online database called CIMA ( Centro de Información de Medicamentos the Drug Information Centre), which incorporates all information regarding medicinal prod- ucts authorised in Spain (through both the national and centralised procedures), as well as those whose MA has been revoked or temporarily suspended. This database does not display information on medicinal products with pending MA decisions or MA applica- tions rejected by the AEMPS. It is important to note that the activity of the AEMPS is subject to the provisions of Law 19/2013 on trans- parency and access to public information. This law states that any interested party may submit requests for access to public information. Based on this regula- tion, it is possible to request that the AEMPS report on the number of pending MA applications for a specific active substance. Based on the firm’s experience with such requests, AEMPS provides information regarding the number of pending MA applications for a given active substance, the submission date of such application, the valida- tion date, the pharmaceutical form, the registration status and the anatomical therapeutic chemical (ATC) code. However, the AEMPS does not disclose details regarding the name of the medicinal product or the applicant company, arguing that this information is confidential and that its disclosure could affect the economic and commercial interests of the applicants, as it forms part of their regulatory strategy. The same rationale applies to requests regarding MAs that have been rejected by the AEMPS. The names of medicinal products whose MAs have been denied, as well as the name of the applicant company, remain confidential. Medical Devices Finally, concerning medical devices, the AEMPS does not maintain a public database of all medical devices
marketed in Spain. The AEMPS only publishes three specific lists of medical devices, indicating the date of notification, the trade name, the composition, the manufacturer and the distributor. These lists refer to: • filler implants used for plastic, reconstructive and aesthetic purposes with CE marking marketed in Spain; • medical devices considered platelet-rich plasma collection systems; and • medical devices that were specifically used dur- ing COVID-19 and were found by the AEMPS to be non-compliant with regulations while on the market. Additionally, Royal Decree 192/2023 created a registry for medical device distributors, requiring companies engaged in distribution activities to register. However, this registry is not yet operational. This Royal Decree also created the AEMPS Marketing Registry, where all medical devices placed on the market, except class I devices, must be registered. This registry is currently only operational for economic operators and is not public. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Fast-track registration routes are available for AEMPS- listed strategic medicinal products. While not explic- itly established by law, these mechanisms have been implemented in practice by the AEMPS. The AEMPS regularly publishes and updates the strategic medici- nal products list on its website, which includes medici- nal products that meet two key criteria: criticality (ie, importance of the therapeutic indication) and vulner- ability (ie, availability of alternative treatments). The list of strategic medicinal products includes clini- cally essential but under-represented treatments in Spain, particularly those containing World Health Organization (WHO) essential active ingredients and those selected by the Food and Drug Administration (FDA). It also includes medicinal products for which cancellation or suspension requests have been denied due to their critical healthcare impact, as well as those
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