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Back in January 2018, the EMA launched a survey to all companies that held a centrally authorised product. The survey was intended to understand the level of preparedness in relation to Brexit.
A summary of the survey is as follows.
The EMA received a high response rate of around 90% of the 180 companies they had contacted. In general, most companies have systems and steps in place to be ready for Brexit. However, around 16% (108 products) where a significant proportion of the activity is from the UK have insufficient plans in place to meet the deadlines. This possibly places the products at risk of not being available to the EU market. Furthermore, there is concern that many companies are planning submissions around Q1 2019, which is the same time the EMA is relocating to the Netherlands. The EMA is encouraging companies to bring submission plans forward to Q4 2018 at the latest, in order to avoid running the risk of delays in processing the changes. The EMA is in the process of following up with companies that have yet to respond to the survey. The situation looks more muddled with veterinary products, since there was a higher percentage of non-responders and thus the EMA was unable to come to any conclusions.
The key messages coming out from the survey are that companies need to be more proactive with their submission plans, and place submissions earlier rather than later. The EMA has made clear indications that there will be a resource and capacity constraint in Q1 2019 due to their relocation, and companies should be prepared for assessments and approvals to be impacted for any changes submitted within that time period.