Brexit - the EU FMD's painful problem
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.
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.”
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance