The negotiation for the final Brexit agreement and a new working-relationship between the EU and the UK still has many twists and turns ahead. From a medical perspective, the European Medicines Agency and EU Commission have published their expectations on the assumption of a Hard-Brexit scenario. The purpose of their intervention was to instruct Market Authorisation Holders (MAHs) to think ahead and be ready to meet EU requirements post-Brexit. Subsequently, all pharmaceutical stakeholders need to consider the effect that these negotiations will have. At Diamond Pharma Services we have provided a detailed analysis on the Hard-Brexit considerations for MAHs and those companies with clinical development assets in the EU.
As an EU consultancy offering regulatory, pharmacovigilance and quality compliance services, we have been approached by a number of clients asking for our view on the effect of Brexit on their business and ours. The plain truth, today, is that we don’t know whether a softer and more collaborative outcome will be achieved. But we need to be ready for any eventuality and act as necessary. With this in mind, we have announced our Brexit Package. At the appropriate time, we will implement the package needed to help our clients remain in compliance in the EU and the UK. Examples of these services and provisions are detailed in the Brexit Package flyer.
Our message is, keep calm and plan, then act at the appropriate time.