Coronavirus: Screening

(asked on 24th June 2021) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason Innova lateral flow tests had their authorisation extended by the Medicines & Healthcare products Regulatory Agency only until 28 August 2021.


Answered by
Jo Churchill Portrait
Jo Churchill
Minister of State (Department for Work and Pensions)
This question was answered on 6th July 2021

An Exceptional Use Authorisation (EUA) is only needed if the lateral flow test is not UKCA, CE, or CE UKNI marked. The Medicines and Healthcare products Regulatory Agency (MHRA) provides EUAs where there are no UKCA, CE, UKNI products available and where there is a clinical and/or public health need. The MHRA has determined this is the case for the re-purposed Innova lateral flow tests. The duration of an EUA can differ for a number of reasons and a shorter extension was considered appropriate for the re-purposed Innova tests. This does not preclude further extensions if requested by NHS Test and Trace.

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