Today, the MHRA has published its latest guidance on the summary of pharmacovigilance system requirements should the UK withdraw from the EU without a deal on 29 March (i.e. under a “no-deal Brexit” scenario). The concept of the UK PSMF is further clarified, as is the requirement for the location of the UK PSMF (which does not mirror the counterpart requirement for the PSMF in the EU/EEA). The practical and procedural context for the UK-based QPPV is also further edified. While there would still be a period of grace of 21 months allowed for companies that have already established a QPPV based in the EU/EEA before they have to switch to a UK-based QPPV for the UK market, it is further reinforced that this would only be a temporary exemption regarding the location of the UK QPPV. As the guidance states, it “…will allow the EU/EEA QPPV who, immediately before exit day, resided and operated in an EEA State, to assume responsibility for UK authorised products until a QPPV who resides and operates in the UK can be established.” The practical guidance, such as to how to procedurally handle the approval of the UK QPPV in relation to UK MAs or apply for a UK PSMF number, is also welcomed.
In PharmaLex UK, we combine our profound knowledge and practical navigation of the EU regulatory environment with equally strong expertise in relation to UK affairs, which means that we are perfectly placed to assist clients with both regional and national level considerations, strategic and tactical in regulatory affairs and pharmacovigilance. As well as offering our customers guidance and advice around Brexit, we continue to engage in a high level of interest from clients and the market in our ability to provide UK representation, with services such as the UK QPPV and local contact person for UK MAs being frequently reserved.
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