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 complex array of requirements and guidelines developed at both EU and EU Member State levels govern the following aspects of medicinal products:
clinical testing (ie clinical trials)
placing on the market (ie marketing authorisations (MA) and regulatory procedure for approval of medicinal products)
protection of the pre-clinical and clinical data developed for the purposes of obtaining an MA (ie regulatory data protection)
manufacture and importation
labelling and package leaflet
advertising and promotion
wholesale distribution and brokering
pricing and reimbursement
medicines for rare diseases (ie orphan medicinal products)
advanced therapy medicinal products (ATMPs)
unlicensed medicines and off-label
**Trials are provided to all LexisPSL and LexisLibrary content, excluding Practice Compliance, Practice Management and Risk and Compliance, subscription packages are tailored to your specific needs. 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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