The following Life Sciences practice 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 of medicinal products.
The safety and protection
**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.
To view the latest version of this document and thousands of others like it, sign-in to LexisPSL or register for a free trial.
Existing user? Sign-in
Take a free trial
Tipping off and prejudicing an investigationIt would undermine the benefit to the authorities if, a suspicious activity report (SAR) having been made, the alleged offender were to be made aware of the interest in their activities so that they could take steps to cover up their misdeeds or disappear.
Fraud by false representationFraud by false representation applies to a broader range of conduct than the offences under the preceding legislation (the Theft Act 1968 (TA 1968)). No gain or loss need actually be made, and no deception need operate on the mind of the deceived for the Fraud Act 2006
BREXIT: UK is leaving EU on Exit Day (as defined in the European Union (Withdrawal) Act 2018). This has an impact on this Practice Note. For further guidance on the impact of Brexit on e-money requirements, see Practice Note: Impact of Brexit: Payment services and electronic money directives—quick
A declaratory judgment is a judgment identifying the rights, duties or obligations of one or more parties in a dispute. It is legally binding, but does not order any action by a party. A court may issue it alone or in conjunction with some other relief such as an injunction and can be granted on an
0330 161 1234
To view our latest legal guidance content,sign-in to Lexis®PSL or register for a free trial.