To ask the Secretary of State for Health and Social Care, if he will publish the (a) detailed performance surveillance plan for monthly reports which he was required to submit to the Medicines and Healthcare products Regulatory Agency under paragraph 17 of the exceptional use authorisation for the Innova lateral flow test that was issued to him on 22 December 2020 by the Agency, Medicines & Healthcare products Regulatory Agency, (b) monthly reports and (c) bi-weekly reports detailing a summary of adverse incidents, the number of devices supplied and to whom, as required under paragraph 10 of the authorisation.
Answered on
17 June 2021
The information requested could only be obtained at disproportionate cost. We plan to publish a summary of the evidence that underpins the use of lateral flow devices and our submission to the Medicines and Healthcare products Regulatory Agency later in the year.