{"id":3654,"date":"2021-05-31T22:50:51","date_gmt":"2021-05-31T21:50:51","guid":{"rendered":"http:\/\/allysonpollock.com\/?p=3654"},"modified":"2021-05-31T22:50:52","modified_gmt":"2021-05-31T21:50:52","slug":"freedom-of-information-requests-to-the-medicines-healthcare-products-regulatory-agency-may-2021","status":"publish","type":"post","link":"https:\/\/allysonpollock.com\/?p=3654","title":{"rendered":"Freedom of Information requests to the Medicines & Healthcare products Regulatory Agency, May 2021"},"content":{"rendered":"\n

1<\/strong>            Further authorisation of Innova LFTs<\/strong><\/p>\n\n\n\n

I note that MHRA\u2019s \u2018authorisation of special use of DHSC COVID-19 Self-Test Kit\u2019 dated 22 December 2020 states that \u201cIf this authorisation ends on 22\/06\/2021, and there continues to be a need for a further authorisation, the position will be reviewed by the MHRA and a decision taken on whether it remains in the interests of the protection of health for a further authorisation or an amendment to this authorisation to be made.\u201d<\/p>\n\n\n\n

I would be grateful if you could inform me whether MHRA has been informed of a need for a further authorisation and, if so, when it will take a decision and what evidence it will take into account to determine whether continued authorisation will protect health.<\/p>\n\n\n\n

\n\n\n\n

2            <\/strong>Use of Innova LFTs<\/strong><\/p>\n\n\n\n

I refer to paragraph 2 of MHRA\u2019s \u2018Authorisation of special use of DHSC COVID-19 Self-Test Kit\u2019 dated 22 December 2020, which states: \u201cThis authorisation is solely for the use in the testing of large sections of the population to detect infection in asymptomatic individuals. We do not currently support the use of the test for a \u2018test to enable\u2019 function until we are satisfied there is evidence to support this.\u201d<\/p>\n\n\n\n

Please inform me whether MHRA has received any evidence to support use of the test for a \u2018test to enable\u2019 function and if so, please specify the evidence.<\/p>\n\n\n\n

\n\n\n\n

3            <\/strong>Changes to components of Innova LFTs<\/strong><\/p>\n\n\n\n

I would be grateful if you would inform me whether DHSC has informed MHRA of any changes to the components of the Innova lateral flow tests authorised on 22 December 2020. If so, kindly provide me with a copy of the information received from DHSC.<\/p>\n\n\n\n

\n\n\n\n

4            <\/strong>Performance and assessment of Innova LFTs<\/strong><\/p>\n\n\n\n

I see that paragraph 4 of the authorisation for the Innova lateral flow tests given to the DHSC by MHRA in December 2020 requires that \u201cthe devices are fit for the purpose intended, will work as intended in line with stated performance and have been assessed as such\u201d. Please inform me of the intended purpose and the stated performance, and provide me with a  copy of any assessment which MHRA holds.<\/p>\n\n\n\n

\n\n\n\n

5            R<\/strong>oll-out of and CE marking for Innova LFTs<\/strong><\/p>\n\n\n\n

Referring to the MHRA letter dated 22 December 2020, \u2018Medical Devices Regulations 2002: authorisation of special use of DHSC COVID-19 self-test-kit\u2019 (ref DEU\/012\/2020\/003), I would be grateful if you could please provide me with a copy of<\/p>\n\n\n\n

a. the distribution and roll-out plan referred to in paragraph 5; and
b. the detailed time plan for CE marking received by MHRA, or a copy of the explanation provided by the DHSC as to why it will not be seeking CE marking, as required by paragraph 9<\/p>\n\n\n\n

\n\n\n\n

6            <\/strong>M<\/strong>onitoring of Innova LFTs<\/strong><\/p>\n\n\n\n

I would be grateful if you would provide me with a copy of  the information MHRA holds about the mechanisms in place for monitoring the performance of the Innova LFT devices as referred to in paragraph 11, of the authorisation for those tests given by MHRA to the DHSC on 22nd<\/sup> December 2020,  and of the evidence which has been obtained as a result of the operation of those mechanisms.<\/p>\n","protected":false},"excerpt":{"rendered":"

1            Further authorisation of Innova LFTs I note that MHRA\u2019s \u2018authorisation of special use of DHSC COVID-19 Self-Test Kit\u2019 dated 22 December 2020 states that \u201cIf this authorisation ends on 22\/06\/2021, and there continues to be a need for a further authorisation, the position will be reviewed by the MHRA and a decision taken on […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[152,162,163],"tags":[154,153,159,158],"class_list":["post-3654","post","type-post","status-publish","format-standard","hentry","category-covid-19","category-freedom-of-information","category-sars-cov-2-testing","tag-coronavirus","tag-covid-19","tag-testing","tag-testing-sars-cov-2"],"_links":{"self":[{"href":"https:\/\/allysonpollock.com\/index.php?rest_route=\/wp\/v2\/posts\/3654","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allysonpollock.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allysonpollock.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allysonpollock.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allysonpollock.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3654"}],"version-history":[{"count":0,"href":"https:\/\/allysonpollock.com\/index.php?rest_route=\/wp\/v2\/posts\/3654\/revisions"}],"wp:attachment":[{"href":"https:\/\/allysonpollock.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3654"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allysonpollock.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3654"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allysonpollock.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3654"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}