Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when approval was sought for the packaging design of covid-19 lateral flow tests by SureScreen Diagnostics; and when that approval was granted.

The Medicines and Healthcare products Regulatory Agency (MHRA) first received an Exceptional Use Authorisation (EUA) application from SureScreen on the 30 September 2021 and after review, approval for the derogation was issued on the 10 November 2021. Whilst we aim to review applications at pace, it is essential that all data is thoroughly assessed.

All packaging and instructions for use are part of the normal review process of an EUA authorisation and the final versions presented to the MHRA were approved on the 23 November 2021.