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An association has inquired whether distributors of empty packaging for medical devices must request a declaration from their customers to apply the tax exemption. The Directorate-General for Taxes (DGT) has ruled that obtaining such a prior declaration is mandatory for empty packaging, but not when the packaging already contains the products.
Cuestión planteada En primer lugar, la consultante pregunta si las entidades distribuidoras que importen o realicen adquisiciones intracomunitarias de envases vacíos que posteriormente van a contener, proteger, manipular, distribuir o presentar productos sanitarios, deberán solicitar a sus clientes (hospitales, clínicas, farmacias, etc…) una declaración en el que se indique el destino sanitario del envase con la finalidad de hacer efectiva la exención del impuesto (artículo 75 a) de la Ley 7/2022).
Para la fabricación, importación o adquisición intracomunitaria de envases vacíos destinados a productos sanitarios, medicamentos o alimentos médicos, es preceptivo recabar una declaración previa de los adquirentes que manifieste su destino para aplicar la exención. Sin esta declaración, no cabe la exención. En cambio, si los envases se importan o adquieren intracomunitaria mente ya prestando la función de contener o proteger dichos productos, no es obligatorio solicitar la declaración previa, aunque se debe acreditar la procedencia de la exención por cualquier medio de prueba.
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