Many EU and U.S. pharma companies are unaware that if a no-deal Brexit is reached between the U.K. and the EU, they will need to meet a crucial EU export administration deadline by March 29, 2019, a regulatory expert has confirmed.
Fiona Barry, associate editor, PharmSource, a GlobalData product, attending the recent Convention on Pharmaceutical Ingredients (CPhI) Worldwide conference in Madrid, commented, “It was interesting to speak to Lynne Byers, executive director of NSF International’s pharma biotech services, who summarized that if drug makers change their drug’s batch release site or have to reapply for a marketing authorization, they will need to repackage their drug, making this Brexit’s biggest and currently least understood impact on pharma companies.”
Currently, new drugs are approved in the EU by a mutual recognition procedure (MRP) whereby a single EU country assesses the product and awards a marketing authorization, which then holds for all EU countries.
In the event of a no-deal Brexit, the U.K. has said that it will automatically grant U.K. marketing authorization to drugs that already have a centralized EU approval after Brexit occurs on March 29, 2019. However, this U.K. license will require a new marketing authorization number that must be placed on the outside of the drug packaging. The same rule applies to products that are currently being sold in the EU after being originally approved in the U.K.; they will require a new marketing authorization number to continue to be sold in the EU.
According to GlobalData’s report: “Brexit and the Healthcare Industry – Implications for Pharma, Q3 2018,” which surveyed pharmaceutical industry leaders within and outside the U.K., companies are already moving their marketing authorizations: One U.K. director’s company had moved “all EU Marketing Authorizations to a legal entity in the EU.”
Barry confirmed, “The U.K. has given companies until the end of 2020 to make these adjustments, but the EU deadline for acquiring a new marketing authorization holder (MAH) within the EU is March 29, 2019.”
It is expected that many countries will give a grace period of six months for companies to change their drug packaging so that the new marketing authorization number is displayed, however Barry added, “As Byers told us on the sidelines of CPhI, this change remains a huge task for pharma companies with large product portfolios which typically have thousands of units in stock.
“Few pharma companies have in-house artwork and design teams preferring instead to outsource their requirements to specialist design agencies. These agencies are typically small to medium sized enterprises (SMEs) and it is unclear whether they or the other suppliers in the packaging supply chain, like contract packaging organizations (CPOs) and contract manufacturing organizations (CMOs) will have the capacity or resources to produce all of the required updated packaging on time across an entire global market.”
As Brexit day nears closer, unanswered questions such as these leave the U.K. a high-risk market for healthcare companies to invest in research and manufacturing.