43 million home (lateral flow) test kits were purchased in December by the Central Jutland authority from the UK-based Medical Supplies Direct company for 825.5 million kroner.
The company is not registered for the sale of medical equipment in Denmark or the EU and has no telephone number or website.
The Danish health authority said that foreign companies are not required to be registered with the Danish Medicines Agency (DMA). It also said that the purchase took place in a situation of high market pressure, and that the brand of the tests had been approved by medical experts.
In a review of the purchase published on Wednesday, Region Central Jutland stated that the DMA had confirmed over the telephone that registration of a supplier with them was not required in order for the tests to be purchased.
That came after Danish newspaper Politiken first reported earlier this week about the purchase of the tests.
In the review, Region Central Jutland CEO Anders Kjærulff said the “entire process (to buy the tests) took place under huge time constraints and in a turbulent market”.
“(It was) also in the period in which Omicron emerged as a Covid-19 variant. This was a market which was new for most of the contractors involved,” he said.
“But the work took place in dialogue with the market and with the national authorities, including medical experts and with focus on relevant legislation,” he said.
The purchase was made by Region Central Jutland on behalf of the Danish state and was, according to the review, requested by the Danish Critical Supplies Agency (Styrelsen for Forsyningssikkerhed).
The product of tests in question, Acon FlowFlex, are reported based on an analysis to detect 94 percent of positive Covid samples.
The Danish region initially tried to buy the tests from another company, Denmark-based CAP Partners A/S, which had provided the analysis of their accuracy. This company then referred the Danish authority to the British firm because it did not have sufficient stock.