SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and In Spain, the distribution of medicinal products can be carried out by entities holding a whole- sale distribution authorisation (WDA), or directly by the MAH or its local representative (LR). Nota- bly, 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 owner- ship transfer and invoicing. Second, in practice, foreign MAHs often rely on an LR that does not physically handle the product. Medical Devices Medicinal Products Typically, the MAH appoints a Spanish company within its group as the LR, entrusting it with all responsibilities related to marketing the prod- uct, 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, own- ership 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
as well as the location and facilities where the manufacturing or control will occur; • have suitable premises and technical and control equipment for the activity intended to be carried out; and • have a technical director, manufacturing manager and quality control manager with sufficient qualifications. The AEMPS will verify that the application meets the formal requirements within ten days and con- duct an inspection at the facilities. The AEMPS will then issue the authorisation resolution, noti - fying the autonomous regions. The maximum time for notification of the resolution is 90 days from the receipt of the application. The authori- sation is valid indefinitely, unless revoked. Medical Devices Companies engaged in the manufacture, impor- tation, grouping or sterilisation of medical devic- es, as well as the facilities where these activities are carried out, require a prior operating licence from the AEMPS. The AEMPS will review the submitted applica- tion and notify its decision within three months from the application date. Operating licences might be refused, suspended or revoked if the documentation provided or inspection reports do not guarantee that the appropriate facilities, means, procedures and personnel are in place. Operating licences are valid for a maximum of five years.
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