The following Life Sciences practice note provides comprehensive and up to date legal information covering:
This Practice Note provides an introduction to the concept of data-ln-csis="393990" data-ln-lnis="5PV7-GPD1-F18F-K3TB-00000-00">borderline products, how the regulatory status of such products is determined in the EU and UK and explores some of the key borderline issues.
The UK regulatory framework for these products has originated from EU law. As a consequence of Brexit, the body of EU-derived laws has been preserved and converted into UK domestic law with effect on IP completion day (11 pm on 31 December 2020). Many principles and requirements derived from EU law have been maintained in UK domestic law, unless specific provisions stipulate otherwise. In addition, under the Ireland/Northern Ireland Protocol, the EU law requirements apply in Northern Ireland. As a consequence, guidance issued by the European Commission may still be relevant to interpret and implement them in the UK where equivalent guidance has not been provided by the Medicines and Healthcare Products Regulatory Agency (MHRA).
For further information on retained EU law, see Practice Note: Introduction to retained EU law while for a discussion on retained EU case law, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit?
It is often obvious whether a product should be classified as a medicinal product, medical
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Entrapment There is no defence of entrapment in English law but it is considered to be an abuse of the process of the court for state agents to lure a person into committing illegal acts and then seek to prosecute him for doing so. The House of Lords said that, although entrapment is not a
Liquidated damages in construction contractsThis Practice Note explains what liquidated and ascertained damages (LADs/LDs) are and their purpose in a building contract. It considers the difference between liquidated damages and general (or unliquidated) damages and looks at the enforceability of
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AffrayAffray is an offence created by the Public Order Act 1986 (POA 1986). It can be tried in either the magistrates’ court or the Crown Court. The magistrates’ court may decline jurisdiction where for example in cases involving a weapon/throwing objects, or conduct that causes serious
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