SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
bution authorisation (WDA), or directly by the MAH or its local representative (LR). Notably, an LR that only purchases (acquires) and sells (invoices) the product, without physically handling it, is not required to hold a WDA. This distinction is important for two reasons. First, it highlights the priorities of the AEMPS regard- ing WDAs. AEMPS is primarily concerned with the physical flow of products and ensuring that any entity handling them holds the necessary regulatory permits. It places less emphasis on financial transactions, such as product ownership transfer and invoicing. Second, in practice, foreign MAHs often rely on an LR that does not physically handle the product. Typically, the MAH appoints a Spanish company with- in its group as the LR, entrusting it with all respon- sibilities related to marketing the product, including invoicing hospitals. At the same time, the LR contracts a third-party logistics provider (3PL) to receive and physically deliver the product to hospitals. In such cases, ownership of the product usually transfers to the LR (from the MAH or another authorised entity) just before hospital delivery, allowing the LR to invoice under its VAT number. From a regulatory perspective, the 3PL must hold a WDA since it physically handles the product, whereas the LR does not require one. Wholesalers and contract warehouses must obtain a WDA from the health authority of the autonomous region where the warehouse is located. This authori- sation will specify the distribution activities the entity is authorised to perform, in accordance with the Euro- pean format. Additionally, these entities must notify the AEMPS before starting their activities. To grant this WDA, the regional authority will verify that such entities have the appropriate personnel, mate- rial and operational means to guarantee the correct development of their activity, as well as the capability to provide a quality service. In addition, a physical inspection of the premises will be carried out. The regional authority must notify its decision within 90 days of receiving the application. If no decision is made within this period, the applicant can consider their application approved. The authorisation is valid indefinitely. However, it may be suspended in the following circumstances:
• if the entity does not fully, effectively and continu- ously carry out all the distribution activities for which it has been authorised one year after the authorisation is granted; or • when the entity no longer meets the requirements that were considered to grant such authorisation or fails to comply with the legally established obliga- tions. Medical Devices Distributors and other entities engaged in the sale of medical devices must submit prior notification of the start of their activity to the health authority of the autonomous region where the company’s registered office is located. They must also notify the health authority of the region where the warehouses are located, if they are in different regions. The notifica- tion must include: • identification of the distribution establishment; • the types of products it distributes or sells; and • identification and qualification of the responsible technician, where applicable. In addition, any entity engaged in the sale of medical devices must be registered in the AEMPS Marketing Register prior to the start of its activity. This register is not yet operational. Once the European Database on Medical Devices (EUDAMED) is fully functional, all devices, except custom-made medical devices, will be reported in the new Medical Device Marketing Register. According to AEMPS Guidelines of April 2025, until that register becomes operational, notifications of placement on the market and putting into service of Class IIa, IIb and III medical devices in Spain must be submitted through the AEMPS application for the noti- fication of the marketing of medical devices ( Comuni- cación de Comercialización de Productos Sanitarios – CCPS). Manufacturers, authorised representatives, system and procedure pack producers or sterilisa- tion service providers established in Spain that place Class I or custom-made medical devices on the mar- ket must notify AEMPS for inclusion in the Register of the Responsible of Medical Devices.
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