SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
in Spain. This database must include the evalu- ation report issued by the AEMPS during the authorisation procedure (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 ( Cen- tro de Información de Medicamentos Drug Infor- mation Centre), which incorporates all informa- tion regarding medicinal products authorised in Spain (through both the national and central- ised procedures), as well as those whose MA has been revoked or temporarily suspended.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 applications 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 transparency and access to public information. This law states that any interested party may submit requests for access to public information. Based on this regulation, it is pos- sible to request that the AEMPS report on the number of pending MA applications for a spe- cific active substance. Based on the authors’ experience with such requests, AEMPS provides information regard- ing the number of pending MA applications for a given active substance, the submission date of such application, the validation date, the phar- maceutical 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 infor- mation is confidential and that its disclosure
could affect the economic and commercial inter- ests 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 appli- cant company, remain confidential. Medical Devices Finally, concerning medical devices, the AEMPS does not maintain a public database of all medi- cal devices marketed in Spain. The AEMPS only publishes three specific lists of medical devic- es, indicating the date of notification, the trade name, the composition, the manufacturer and the distributor. These lists refer to: • filler implants used for plastic, reconstruc- tive and aesthetic purposes with CE marking marketed in Spain; • medical devices considered platelet-rich plasma collection systems; and • medical devices that were specifically used during 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, requir- ing companies engaged in distribution activi- ties 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 cur- rently only operational for economic operators and is not public.
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