Brexit: Preparing Is Caring
Most UK pharma companies are on track to keep their medicines on the European market by March, 2019, according to an EMA survey. But “serious concerns” remain for a significant minority
James Strachan |
Brexit talks are at an impasse over the question of the Irish border. And unless a mutually acceptable “backstop” – to prevent the need for new infrastructure at the Irish border – can be found, there will be no Withdrawal Agreement, no transition, and no deal. As of March 30, 2019, the UK would become a “third country,” where all EU primary and secondary law ceases to apply.
For marketing authorization holders (MAHs) in the UK, steps must be taken now to ensure that products can remain on the EU market after March 29. These include: transferring the marketing authorization to a MAH based in the European Economic Area (EEA), as well as changing the location of the Qualified Person for Pharmacovigilance (QPPV), pharmacovigilance system master file (PSMF), batch release, quality control and importation sites, to the EEA.
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