The following Life Sciences practice note provides comprehensive and up to date legal information covering:
11 pm (GMT) on 31 December 2020 marked the end of the implementation period put in place to enable the UK to transition away from the EU’s laws and institutions. At that point in time (referred to in this document as ‘IP completion day’) there was an immediate and significant change in the UK’s legal regime. This Practice Note explains the implications of this change in relation to the following aspects of clinical trials:
Overview—what happened on 31 December 2020
How does Brexit impact clinical trials?
What are the key legal authorities in this area?
What guidance is available from the UK government?
What guidance is available from the EU?
What are the key items of retained EU law? Are they subject to amendment from IP completion day?
What are the key requirements for sponsors from IP completion day?
What are the key requirements for clinical trial registrations from IP completion day?
What are the key requirements for the submission of clinical trial information and safety reports from IP completion day?
What are the key requirements for the supply and import of investigational medicinal products (IMPs) from IP completion day?
What are the key requirements for the publication of clinical trial results from IP completion day?
What is the sector/market approach?
What is in the pipeline beyond IP completion day?
What are the key
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An intention to create legal relations is requiredThere are various situations in which a court will hold that an agreement is not binding because, though supported by consideration, it was made without any intention of creating legal relations (see, eg, Blue v Ashley).Did the parties intend to
Source of the doctrine of the separation of powersThe origins of the doctrine are often traced to John Locke’s Second Treatise of Government (1689), in which he identified the 'executive' and 'legislative' powers as needing to be separate.‘… it may be too great a temptation to human frailty, apt to
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IntroductionShari'ah (also Sharia, Shariah or Shari’a) (literally, in Arabic, 'the path towards the watering place') or Islamic law is the legal system of the religion of Islam that sets out a system of duties or code of conduct for individuals to follow so that they may live their life in a
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