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V1439-21 17 May 2021 · SG de Impuestos sobre el Consumo Criterion in force
IVA · tipo impositivo

0% VAT rate applies only to SARS-CoV-2 in vitro diagnostic medical devices complying with EU regulations

A company requested clarification on whether its pharmaceutical products and diagnostic reagents could qualify for the 0% VAT rate. The Directorate-General for Taxes (DGT) ruled that this rate is exclusively applicable to SARS-CoV-2 in vitro diagnostic medical devices that comply with Directive 98/79/EC or Regulation (EU) 2017/746.

The question raised

Question posed: Application of the 0 percent tax rate approved by Royal Decree-Law 35/2020 for the supply of medical materials.

The DGT's ruling

The 0% VAT rate and the equivalence surcharge apply exclusively to SARS-CoV-2 in vitro diagnostic medical devices that comply with Directive 98/79/EC or Regulation (EU) 2017/746. The 0% rate also applies to transport, storage, and distribution services related to said products. The application of this rate depends on the product meeting the technical requirements of European regulations, the competence for interpreting the scope of this concept lies with the AEMPS.

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