On 21 December 2020, the Corona Crisis Emergency Measures Decree (the Decree) was extended. In the Decree, the State Secretary for Finance approved that no VAT will be levied on the supply of COVID-19 test kits nor on the services closely linked to those test kits. This also applies to the supply of COVID-19 vaccines and to the service closely linked to those vaccines. Not charging VAT does not have a negative impact on the right to a VAT refund of the person applying the approvals. The approvals apply with retroactive effect from 21 December 2020 up to and including 31 March 2021. The same approval already applied for the supply of mouth masks. This approval has been extended up to and including 31 March 2021.
Requirements for COVID-19 test kits and COVID-19 vaccines
The exemption from charging VAT is linked to the possibility of applying the so-called ‘zero rate’. Henceforth, the zero rate can be applied to test kits that comply with the requirements of the Directive on in vitro diagnostic medical devices. In short, these test kits must qualify as an in vitro medical device and they must have a CE marking. The Dutch Decree also states that the test kits must comply with the requirements as laid down in the most recent version of the Dutch National Institute for Public Health and the Environment (RIVM) LCI Guideline COVID-19 and its appendix ‘Supplementary information for COVID-19 diagnostics’ (the appendix) (in Dutch: ‘de LCI-richtlijn COVID-19’ and ‘Aanvullende informatie diagnostiek COVID-19’).
The LCI Guideline COVID-19 and the appendix provide limited guidance for assessing the scope of the zero rate on the supply of test kits. It is not entirely clear what exactly is meant by a ‘COVID-19 test kit’ and whether, for example, (separately available) components or accessories of a test kit and test analysis devices also fall under the applicability of the zero rate.
To apply the zero rate on COVID-19 vaccines and its linked services, the vaccines must be approved by the European Medicines Agency (EMA).
In vitro diagnostic medical devices
According to the In Vitro Diagnostic Medical Devices Decree (in Dutch: Besluit in-vitro diagnostica (Bivd)), an in vitro diagnostic medical device is defined as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information (…)”. The definition refers to information such as a physiological or pathological state. That includes information about the infection with the coronavirus. This definition corresponds with the definition in the Directive on in vitro diagnostic medical devices.
LCI Guideline and the appendix
According to the LCI Guideline and the appendix, testing can be done by reverse transcription PCR tests or other nucleic acid amplification technique (NAAT) tests. Antigen rapid tests are also mentioned in the LCI Guideline and the appendix. The Status validation anitgen rapid tests of the RIVM gives an overview of the information available from the evaluation process of the validation of the various antigen rapid tests. The overview can serve as an aid in determining whether an antigen rapid test complies with the requirements.
The zero rate was already applied to the supply of medical and non-medical mouth masks. With the Dutch Decree, the approval for applying that zero rate is extended up to and including 31 March 2021.
If you have any questions about the zero rate or if you need help in assessing whether you can apply the zero rate, please contact our Life Sciences Team.