Covid-19 Regulatory Flexibilities

[Stephen-Grayson]

The MHRA has introduced some flexibility during the current Covid-19 outbreak as outlined in the link below:

https://www.gov.uk/guidance/information-for-hospital-blood-banks-during-the-coronavirus-covid-19-outbreak

[volenga]

Thanks you

[Hnabakka]

[QUOTE=Stephen-Grayson;6112]The MHRA has introduced some flexibility during the current Covid-19 outbreak as outlined in the link below:

https://www.gov.uk/guidance/information-for-hospital-blood-banks-during-the-coronavirus-covid-19-outbreak
[/QUOTE

Could the MHRA consider extending the Blood Compliancereport deadline to say 30/06/2020 instead of leaving it flexible? Saying it’sflexible but then having to justify why the report is late, still adds pressure to the HBB to try and submit by 30/04/2020.

[Shirley-Stagg]

Dear Hnabakka

The MHRA did not assign a fixed date for the BCR extension in order to allow full flexibility. Those HBBs that can submit their BCR on time should do so. Our expectation is that the justification provided for an extension will be a short couple of sentences relating the reason to the current COVD-19 situation - this will allow us to have an overall picture of the impact of the situation.

If the regulatory flexibilities we have published so far do not provide enough scope for HBBs then please report any further difficulties to the MHRA via bcr@mhra.gov.uk or gmpinspectorate@mhra.gov.uk

[Shirley-Stagg]

Please be aware of other flexibilities published on the MHRA website that may be useful for Blood Establishments and Hospital Blood Banks

https://www.gov.uk/guidance/guidance...coronavirus-co

[Hnabakka]

Thank you Shirley for the clarification.