Medicines & Healthcare Products Regulatory Agency

Prior to 2021 MHRA had manageable levels of information requests and systems in place which were sufficient to cope with those volumes. However, volumes and the complexity of information requests (especially with the introduction of covid vaccines) has increased from 2021/2022 onwards and it has become increasingly apparent that its systems and procedures are no longer fit for purpose or sufficient to meet increased volumes and increasing levels of complexity.

MHRA has therefore shown a declining trend in performance in terms of the time limits for complying with information requests. It has also consistently failed to carry out internal reviews within the recommended timeframes. Following engagement by his staff with MHRA about the underlying reasons for these failings, the Commissioner has reached the view that MHRA’s request handling practices do not conform to parts 4 and 5 of the section 45 Freedom of Information Code of Practice, issued by the Cabinet Office in July 2018 (the Code).