Many EU and US pharma companies are unaware that if a no-deal Brexit is reached, they will need to meet a crucial EU drug packaging deadline.
In the event of a no-deal Brexit, the UK has said that it will automatically grant UK marketing authorization to drugs that already have a centralized EU approval after Brexit occurs on March 29 2019, the EU drug packaging deadline also falls on this date. However, this specific UK 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 UK; they will require a new marketing authorization number to continue to be sold in the EU.
EU drug packaging deadline
Fiona Barry, Associate Editor, PharmSource, a GlobalData Product, attending the recent Convention on Pharmaceutical Ingredients (CPhI) Worldwide conference in Madrid, commented on the situation: “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.
According to the GlobalData report ‘Brexit and the Healthcare Industry – Implications for Pharma, Q3 2018’, companies are already moving their marketing authorizations. The report surveyed pharmaceutical industry leaders within and outside the UK, and one UK Director’s company had moved EU Marketing Authorizations to a legal entity within the EU.
Brexit is coming
Barry confirmed, “The UK 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 period of six months for companies to change their drug packaging so that the new marketing authorization number is displayed, this should ideall help companies to overcome the EU drug packaging deadline.
Barry adds: “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 quickly approaches, unanswered questions such as these leave the UK a high-risk market for healthcare companies to invest in research and manufacturing.