The following Life Sciences practice note Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn 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.
In the EU, Article 6 of Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code establishes the general rule that no medicinal product may be placed on the EU market without first having been granted a marketing authorisation (MA) by the relevant competent authority (ie the European Commission in the case of centrally authorised medicinal products or a national competent authority in the case of decentralised, mutual recognition or purely national authorisation procedures). See Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products. In the UK, the Pharmaceutical Code is implemented by the Human Medicines Regulations 2012 (HMRs), SI 2012/1916. HMRs, reg
**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
On 29 August 2015, the Prudential Regulation Authority (PRA) published the PRA Rulebook (Rulebook). The transition from the Handbook to the Rulebook was intended to benefit PRA-authorised firms, to access clearer and more concise rules. Alongside the Rulebook, supervisory statements and statements
What are OFTOs?Offshore Transmission Owners (OFTOs) are the owners of offshore transmission assets which connect offshore wind farms to the onshore electricity network. The transmission assets comprise everything between the offshore point of connection with the generating wind farm assets and the
The primary function of office-holders in personal and corporate insolvency is to collect in the assets belonging to a company or individual and to distribute these to the company's or individual's creditors. Office-holders have various duties and powers in order to ensure that they do this. For
This Practice Note considers the legal concept of mistake in contract law. It examines common mistake, mutual mistake, unilateral mistake, mistake as to identity and mistake as to the document signed (non est factum). It also considers the impact of each of these types of mistake on the contract and
0330 161 1234
To view our latest legal guidance content,sign-in to Lexis®PSL or register for a free trial.