Following on the exit of the UK from the EU on 31st Jan 2020, this year’s MHRA Good Pharmacovigilance Practice (GPvP) Symposium was well attended and eagerly awaited by the pharmacovigilance professionals within the industry.
Very little, however, was shared regarding what the future UK pharmacovigilance requirements may be after the transition period, as these will depend on the outcome of ongoing negotiations.
The MHRA confirmed that, should the UK and the EU not reach an agreement by the end of December 2020 (and the transition period is not extended), the previously published guidance for a no-deal Brexit will come into effect as a default on 1st Jan 2021. However, there was a clear expectation that such guidance will change as the negotiations between the UK and the EU move forward.
Pending communication of future requirements, the MHRA indicated that if the requirement for a UK QPPV and UK PSMF were to come into effect by the end of December 2020, MAHs will have a 21-month period from 1st Jan 2021 to put this requirement into place.
Reassurance did come out of the meeting, as the MHRA stated that they are ready to meet the challenges of the exit and that there will be no disruption; guidance will be provided and there will be no expectation for industry to be ready and ‘up and running’ with all new requirements by 1st Jan 2021.
If you need more information or any support on this topic, ASPHALION’s new PV contact in the UK (Maria Molist) is always on hand to help you. Do not hesitate to contact us at [email protected]
