On 23 August 2018, the UK Government (the "Government") issued the first wave of its technical papers designed to provide guidance to companies to help prepare for a "No Deal" Brexit. In this scenario, there will be no "transition period" but rather the UK will simply become a third country to the European Union ("EU") from 29 March 2019. The full guidance paper for human medicines regulation can be found here, and a summary of its key provisions below. In addition, there are other relevant notices on batch testing, found here, and on submitting regulatory information on medicinal products, which can be found here. From the guidance, it is clear that the Government's intention is to maintain regulatory alignment with the EU. The Medicines and Healthcare products Regulatory Agency ("MHRA") will be undertaking a consultation in the autumn, so a more comprehensive technical notice is expected to be issued after that.
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