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Dear all
During the October 2020 PV Webinar, the MHRA confirmed in a verbal statement that there wouldn’t be any personal legal liability associated with the UK QPPV role and any penalties would sit with the MAH.
Our company has plans to continue to use our current EU QPPV also as QPPV for the UK. We’ve been advised by our QPPV that EFPIA are currently discussing the issue and some QPPVs disagree with the MHRA’s statement.
If they’re correct, the UK QPPV would need a UK professional indemnity insurance from 1st Jan 2021. We’d be interested to see if other companies have discussed this or/and have made any arrangements already (or perhaps raised this with the MHRA/ABPI or their legal departments).
This was discussed at the July 2020 PIPA Live webinar and is available as a recording. The below formed part of the discussion:
EU QPPV’s would require professional indemnity insurance as they are personally responsible for the PV system.
There are some specialist insurers out there that offer this, check the January PIPELINE edition for one such company’s advertisement.
With regards to bringing in house the deputy EU QPPV role and remain with an out sourced EU QPPV; this is a well-trodden road. You will need to ensure that there is clear and documented communication, including back-up processes, absence cover etc. between the parties.
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