The following Life Sciences guidance note provides comprehensive and up to date legal information covering:
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.
A clinical trial is an investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a medicinal product, ie it assesses a medicine’s efficacy and safety. In the EU, clinical trials must be conducted on new medicinal products before they can receive approval to be placed on the market, but clinical trials are also conducted on medicinal products which are already available to the public in order to demonstrate their efficacy compared to competing products or placebos. For more information on marketing authorisations (MAs) in the EU, see Practice Note: Marketing authorisations—regulatory procedures for approval
**excludes LexisPSL Practice Compliance, Practice Management and Risk and Compliance. To discuss trialling these LexisPSL services please email customer service via our online form. Free trials are only available to individuals based in the UK. We may terminate this trial at any time or decide not to give a trial, for any reason. Trial includes one question to LexisAsk during the length of the trial.
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