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1400128
registered interest false more like this
date less than 2022-01-05more like thismore than 2022-01-05
answering body
Department of Health and Social Care remove filter
answering dept id 17 more like this
answering dept short name Health and Social Care more like this
answering dept sort name Health and Social Care more like this
hansard heading Coronavirus: Screening more like this
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty's Government, following the introduction of updated COVID-19 test validation approval processes (CTDA), what guidance is available to testing manufacturers regarding submitting applications (1) for new tests and (2) for an updated approved product; and what is the expected timescale from application to decision for such applications. more like this
tabling member printed
Baroness Finlay of Llandaff more like this
uin HL5111 more like this
answer
answer
is ministerial correction true more like this
date of answer less than 2022-03-07more like thismore than 2022-03-07
answer text <p><del class="ministerial">On 21 February 2022, the Government accepted advice from the Joint Committee on Vaccination and Immunisation (JCVI) on offering a further dose to some individuals. The primary aim is to reduce the risk of severe disease across the population. As protection against severe COVID-19 disease declines slowly, the most vulnerable groups have been prioritised for vaccination.</del></p><p><del class="ministerial">A dose will be offered to those over the age of 75 years old, residents in care homes for older adults and people aged 12 years and over who are immunosuppressed. The JCVI continues to consider the latest available data on the timing and value of further doses.</del></p><p><ins class="ministerial"> <p><ins class="ministerial">The online only guidance COVID-19 test approval: how to apply advises testing manufacturers on the validation process for new devices. The guidance sets out the process from submitting an application; the desktop review; how payment can be made; the outcome reporting on tests which have passed; how to make a complaint; and where an application is unsuccessful, how the manufacturer can request a review of the decision.</ins><ins class="ministerial"></ins></p></ins><ins class="ministerial"><p><ins class="ministerial">For updates to products while an application is being considered, applicants must inform the COVID-19 Test Device Validation Approval processes (CTDA) administration team and provide the updated Instructions for Use. For updates to approved products, manufacturers are encouraged to contact the CTDA administration team. Guidance for such updates is currently being developed.</ins></p><p><ins class="ministerial">The CTDA team aim to have the results of the application review within 20 working days of submission, subject to the application being complete. This process may take longer where there is a high volume of applications and if there are additional queries on the data submitted.</ins></p></ins></p>
answering member printed Lord Kamall more like this
question first answered
remove filter
question first ministerially corrected
less than 2022-03-10T11:19:47.947Zmore like thismore than 2022-03-10T11:19:47.947Z
answering member
4909
label Biography information for Lord Kamall more like this
previous answer version
55652
answering member printed Lord Kamall more like this
answering member
4909
label Biography information for Lord Kamall more like this
tabling member
3609
label Biography information for Baroness Finlay of Llandaff more like this