Further to the Brexit, all Union laws cease to apply to the United Kingdom from 30th March 2019. The “transition period”, which foresees that the Union laws will continue to apply to the UK until 31st December 2020 without the participation of United Kingdom in the decision making of EU institutions and bodies, is not agreed upon and it seems advisable to assume the worst-case scenario of a hard Brexit.
To be prepared to face the worst-case scenario, the pharmaceutical companies are strongly recommended to check whether the regulatory activities of their business affected by the Brexit (e.g. marketing authorisation, batch release, QPPV location) have been duly assessed in order to meet the deadline of 30th March 2019 to complete the “transfer” process.
RPN can support companies in evaluating how Brexit will impact on their situation and in preparing a check list and an action plan to deal smoothly with a hard Brexit.