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 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 use of authorised medicines
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This Practice Note explains certain common financial covenants used in commercial finance transactions including:•minimum net worth test•gearing ratio•leverage ratio (or debt to equity ratio)•current ratio (or acid test ratio)•cashflow ratio•interest cover ratio, and•loan to value ratioIt explains:
Codicils may be used for making any alteration in a Will such as to alter the executors or make changes in legacies, whether by addition or deletion but that is by no means their only use. As a general rule, substantial changes are best achieved by means of a new Will and codicils are more
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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
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