by John Cahill Director/Snr Consultant, Quality and Compliance
A disorderly Brexit is moving from a possibility to a probability. While governments pass last minute legislation over the month of March, it is encouraging to be part of a responsible industry that treats the threat to patients very seriously and has, according to our government officials, prepared very well for the changes ahead. Nevertheless, the UK is a global top ten producer and market of medicines, and when the UK becomes a third country the impact of the separation of regulatory jurisdictions should not be underestimated.
Over the past 18 months, many organisations have approached PharmaLex requesting assistance in the risk management of their operations to prepare for Brexit. We recently received a request for a “Brexit Checklist”. It got us thinking if a ‘one-stop shopping list’ of checks, that will reassure an organisation that it has prepared their manufacturing and supply operations for Brexit, could exist? Unfortunately, no such exhaustive list currently exists. The size and complexity of the UK connection with the global pharmaceutical industry coupled with the regulatory nuances of the separation may be challenging to simplify into a single checklist.
However, we like a challenge at PharmaLex and we thought we would attempt a template for a high-level checklist. Even if we capture 90% of the activities that should be verified, it would be a good start for any operation with doubts on their Brexit preparedness to answer the questions in Table 1.
If the answers to the questions posed in Table 1 are found in the red boxes, we would suggest that you consider carefully the actions your organisation has taken to be compliant with EU regulations after March 31st, 2019.
We, at PharmaLex, can support your organisation in many ways including the provision of regulatory support for MAH’s and the delivery of a collaborative response to any technical queries that you may have in relation to Brexit. Please connect with us to discuss +353 1 846 4742 or email us at email@example.com.