Brexit’s trick or treat on patient safety

Despite the delay to Brexit, pharmaceutical companies still have limited guidance on the regulatory landscape following the UK’s exit from the European Union (EU). This includes the potential impact on the recently implemented EU Falsified Medicines Directive (FMD).

Without clear guidance on the UK’s intentions, patient safety and the continuity of drug supply are at risk.

After months of preparation for the EU FMD enforcement date, pharmaceutical companies are now faced with more uncertainty as a result of Brexit. Will drug products circulated in the UK still need to meet FMD requirements post-Brexit? Will the MHRA introduce alternative measures to combat drug counterfeiting challenges in the UK pharmaceutical supply chain?

Without clear guidance from the regulatory bodies in the UK and EU, pharmaceutical manufacturers have to put contingency plans in place to cover the worst-case scenario. In this Q&A with CPhI Online Staffan Widengren, director of corporate projects at Recipharm discusses what Brexit could mean for EU FMD and the steps companies can take to limit the impact on their operations.

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