Brexit - the EU FMD's painful problem

7 Feb 2019

Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.

Now, after 5 years of preparation and with the compliance deadline only weeks away, the lack of clarity around Brexit remains an obstacle for pharma companies operating on both sides of the Channel.

Brexit - the EU FMD's painful problem

So, what does Brexit mean for the FMD?

We ask industry leader - Daniel Tedham, Managing Director, Wasdell Manufacturing a division of the Wasdell Group - about the current state of the exit agreement, the possibility and problems of a ‘no deal’ and the impact on the UK and European pharmaceutical industries.

What will be the impact of Brexit on the FMD?

Tedham: “There is still a lot of uncertainty surrounding the impact that Brexit will have on the EU FMD regulations. The date for the UK’s exit from the EU is the 29 March 2019, meaning up until this date the UK will legally need to comply with all EU legislation including the EU FMD.

“The Medicines and Healthcare products Regulatory Agency (MHRA) has recently released guidance which outlines an implementation period between 30 March 2019 and 31 December 2020, during which time the UK pharmaceutical industry would continue to meet all EU FMD requirements while the UK authorities work to develop a system that will work alongside the EU’s.”

What are the implications of a ‘no-deal’ Brexit?

Tedham: “While the UK will still have its own Medicines Verification Systems – the UKMVS – it would also need continued access to the European Medicines Verification System (EMVS) to allow the FMD legislation to be fully effective. In the event of a ‘no-deal’ Brexit this is not guaranteed.

“The logistics of how this will work are not yet fully understood. The political fallout of a hard Brexit could potentially affect patient safety due to reduced access to vital medicines and delays in accessing critical information.”

What are companies doing to ensure operations are unaffected by Brexit?

Tedham: “Many UK-based companies have opted to create contingency plans, establishing a presence in the EU or forming partnerships with third parties to ensure sufficient resource for additional release testing requirements. At Wasdell, we are building a new facility in Dundalk, Ireland to ensure business continuity for our customers. We have also started to develop bespoke alterations to supply chains to ensure minimal impact, regardless of the outcome of Brexit negotiations.”

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