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Mar 20
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Impact to UK-based Pharmacovigilance in Event of No-Deal Brexit

With Brexit looming on the horizon, the UK Government have published guidance surrounding what changes would have to be made to current pharmacovigilance processes if the UK were to leave the European Union without a deal. The link above contains material in relation to establishing elements of the UK pharmacovigilance system, including a UK Qualified Person for Pharmacovigilance (QPPV) and a UK Pharmacovigilance System Master File (PSMF).

It is not currently known whether the UK will leave the EU in a “no-deal” scenario on 29 March 2019; however the Medicine and Healthcare Regulatory Agency (MHRA)’s material, cited in the link above, has been produced to facilitate companies’ preparation.

In the event of a no-deal Brexit, UK-based Marketing Authorisation Holders (MAHs) would become legally obliged to operate a pharmacovigilance system for medicinal products authorised in the UK. They would also need to have a QPPV who lives and undertakes their work in the UK.

Equally, they would be required to maintain a UK-specific PSMF located within the UK, which describes the pharmacovigilance system for products authorised in the UK.
Those who will require applications for a UK Marketing Authorisation (MA) would also need to submit the initiating sequence data and related information regarding their application in Electronic Common Technical Document (eCTD) format. Applicants would have a deadline of exactly one year after Brexit to do this (i.e. by 29 March 2020 at the latest).

For general enquiries regarding the UK QPPV, UK PSMF and establishment of pharmacovigilance systems for UK authorised products in the event of a no-deal Brexit, please contact for more information.

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