Results 1 to 6 of 6

Thread: Covid-19 Regulatory Flexibilities

  1. #1
    Moderator
    Join Date
    Jun 2016
    Location
    Hertfordshire
    Posts
    36

    Covid-19 Regulatory Flexibilities

    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

  2. #2
    Thanks you

  3. #3
    Forum Member
    Join Date
    Nov 2017
    Posts
    4

    Request Extension to Compliance report Deadline

    [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.


  4. #4
    Forum Member
    Join Date
    Sep 2018
    Posts
    18
    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

  5. #5
    Forum Member
    Join Date
    Sep 2018
    Posts
    18

    Alternative courses of action for laboratory equipment during the COVID-19 outbreak

    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

  6. #6
    Forum Member
    Join Date
    Nov 2017
    Posts
    4
    Thank you Shirley for the clarification.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •