Brexit and pharmaceutical packaging, the impact and solution.

Despite “details” still being subject to negotiation, Brexit is upon us and will have a major impact on all sorts of businesses inside as well as outside of the United Kingdom. After months of negotiations, many questions regarding Brexit remain unanswered. Companies have to deal with these uncertainties in various ways. One of the main issues is whether the Brexit will be a “soft” one or a “hard” one. The outcome is vital for many organizations, since it will determine the amount of adaptations they will have to make in order to keep their current workflow in place. Some changes are imminent, regardless of what kind of Brexit will be decided on. Some companies will have to move their offices because they simply want/need to stay on EU soil. Others will have to open a new office on European mainland in order to keep their reach at a satisfactory level. But of course Brexit is way more complex than just moving around desks and offices. If we take a closer look at the pharma industry for instance, we see a sector that has to partially reinvent itself due to changing regulations.

Direct impact on the pharmaceutical industry

An example: at this moment, drugs can be produced and sold all over the European Union once it has been approved by a single member of the European Union (thanks to the so called Mutual Recognition Procedure (MRP)). This member then awards a marketing authorisation which holds for all other members (source). If the Brexit committee fails to formulate new, fitting regulations concerning this matter, the industry will need to find a solution for drugs approved in the UK. And even if regulations are formulated, packaging and labelling artworks will have to be updated with a new marketing authorisation number. This applies for drugs approved in the EU and sold in the UK, and the other way round. These changes come on top of artwork updates due to stricter serialization requirements, set by the EU’s Falsified Medicines Directive (FMD). Most pharmaceutical production plants are still struggling to get all their artwork aligned by February 2019, the deadline for EU serialization. While not all pharmaceutical companies create their own artworks, most artwork updates have to be outsourced. For those who do, hiring or insourcing additional resources might be needed. This raises the issue of an enormous increase in workload for design-, artwork- and other studios. The United Kingdom plans to officially leave the European Union on March 29th 2019. Ideally pharmaceutical (and other) companies have their packaging and labelling alterations settled by then. A transition period has been agreed between the UK and the EU in case of a soft Brexit. But this period might disappear in case of a hard Brexit.


Sirius Graphics and packaging, an ideal combination

Sirius Graphics is a European premedia partner specialized in packaging artworks for pharmaceuticals, FMCG and other. Our graphic experts have over 15 years of international experience in packaging and labeling artworks for pharmaceutical companies. As we have all necessary expertise and knowledge in-house, we are prepared and ready for Brexit’s impact and the challenges this brings to our clients. Don’t hesitate to visit our website to check out satisfied customers and successful projects. Thanks to our flexible and right-first-time style of working, we will counter your packaging, labelling and other graphic challenges with an appropriate solution.